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    Fogsi Position Statement On The Use of Progestogens

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    Raviraj Tiruke
    The document provides guidelines on the use of progestogens from the Federation of Obstetric and Gynecological Societies of India. It discusses that progesterone is essential for maintaining early pregnancy and outlines appropriate uses and dosages of micronized progesterone and dydrogesterone for luteal phase support in assisted reproduction and for recurrent pregnancy loss or threatened miscarriage. It notes that available evidence indicates progesterone supplementation in these contexts is safe and can help reduce miscarriage risk, with no significant difference in congenital abnormalities seen in clinical studies.

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    Fogsi Position Statement On The Use of Progestogens

    Uploaded by

    Raviraj Tiruke
    46 views9 pages
    The document provides guidelines on the use of progestogens from the Federation of Obstetric and Gynecological Societies of India. It discusses that progesterone is essential for maintaining early pregnancy and outlines appropriate uses and dosages of micronized progesterone and dydrogesterone for luteal phase support in assisted reproduction and for recurrent pregnancy loss or threatened miscarriage. It notes that available evidence indicates progesterone supplementation in these contexts is safe and can help reduce miscarriage risk, with no significant difference in congenital abnormalities seen in clinical studies.

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    Progesterone

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    Progesterone-position-paper-Oct-2015

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    The document provides guidelines on the use of progestogens from the Federation of Obstetric and Gynecological Societies of India. It discusses that progesterone is essential for maintaining early pregnancy and outlines appropriate uses and dosages of micronized progesterone and dydrogesterone for luteal phase support in assisted reproduction and for recurrent pregnancy loss or threatened miscarriage. It notes that available evidence indicates progesterone supplementation in these contexts is safe and can help reduce miscarriage risk, with no significant difference in congenital abnormalities seen in clinical studies.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    46 views9 pages

    Fogsi Position Statement On The Use of Progestogens

    Uploaded by

    Raviraj Tiruke
    The document provides guidelines on the use of progestogens from the Federation of Obstetric and Gynecological Societies of India. It discusses that progesterone is essential for maintaining early pregnancy and outlines appropriate uses and dosages of micronized progesterone and dydrogesterone for luteal phase support in assisted reproduction and for recurrent pregnancy loss or threatened miscarriage. It notes that available evidence indicates progesterone supplementation in these contexts is safe and can help reduce miscarriage risk, with no significant difference in congenital abnormalities seen in clinical studies.

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    FOGSI POSITION

    STATEMENT ON THE USE


    OF PROGESTOGENS
    Under the guidance of GCPR Incharge, Dr Sanjay Gupte, in the FOGSI Presidential
    tenure of Dr Prakash Trivedi (2015) and Dr Suchitra Pandit (2014)

    Conveners : Dr. Ameet Patki, Dr. Suchitra N. Pandit

    Members of the National Task Group


    I. Use and Misuse of Progesterone

    Dr. Ameya Purandare (Chairperson) Dr. Anuradha Khanna (Co-chairperson)


    Dr. Manish Pandya Dr. Madhu Bala
    Dr. Girija Wagh Dr. AB Chitra
    Dr. Durga Shankar Das Dr. Pratap Kumar
    Dr. Y Savitha Devi
    II. Progesterone Support in Threatened Miscarriage And Recurrent Pregnancy
    Loss

    Dr. Prakash Trivedi (Chairperson) Dr. Bhaskar Pal


    Dr. Vanie Thapar Dr. Meeta Singh
    Dr. Arachna Baser Dr. Umesh Jindal
    Dr. Indu Singh Dr. Santhi Gunasingh
    Dr. B Dhorepatil Dr. Sanjeeva Reddy
    Dr. Alok Sharma
    III. Progesterone Supplementation for Luteal Support in ART

    Dr. Sonia Malik (Chairperson) Dr. Jayam Kannan (Co-chairperson)


    Dr. Ratnabali Dr. Nandita Palshetkar
    Dr. Sanjivini Khanna Dr. Rishma Dhillon
    Dr. KK Roy Dr. Bani Mitra
    Dr. Raju Nair Dr. Gautam Khastgir
    IV. Safety Aspect of Progesterone

    Dr. Mala Arora (Chairperson) Dr. Ritu Joshi (Co-chairperson)


    Dr. KD Nayar Dr. N Sundari
    Dr. Rajat Mohanty Dr. Lovleen Sodhi
    Dr. Leela Vyas Dr. Bavin Balakrishnan
    Dr. Ramani Devi

    1 | Page
    PROGESTERONE AND ITS ROLE IN EARLY PREGNANCY

     Progesterone is an essential hormone needed to maintain pregnancy.

     After ovulation, endogenous progesterone is produced by the corpus luteum


    and it rises sharply and peaks the following week.

     If the ovum is not fertilized, ovarian progesterone production falls,


    triggering endometrial shedding and menstruation. If the ovum is fertilized
    and it implants into the endometrium, the corpus luteum continues to secrete
    progesterone to prevent endometrial shedding, thereby protecting the
    developing fetus.

     Later in pregnancy, the placenta takes over progesterone production, a


    switch that is regulated by the hormone human chorionic gonadotrophin
    (hCG).

    MICRONIZED PROGESTERONE AND DYDROGESTERONE

     Endogenous Progesterone is derived from cholesterol steroids and produced


    mainly by the corpus luteum and the placenta, with some contribution from
    the adrenal glands.

     It has a half-life of about 5 minutes and is metabolized mainly by the liver to


    pregnanediol. In the bloodstream, progesterone is bound mostly to albumin.
    When taken orally, exogenous progesterone is absorbed rapidly, but almost

    2 | Page
    the entire dose is expected to be metabolized completely in one pass through
    the gut and liver. Hence, the vaginal route or injectable route is preferred for
    administration of exogenous progesterone.

     Both micronized progesterone and dydrogesterone are derived from a plant


    source. i.e. Diosgenin (a plant source - Dioscorea villosa )

     Micronization is the process of reducing the average diameter of particles


    such that the particles that are produced are only a few micrometers in
    diameter.

     Dydrogesterone (6-dehydro-retroprogesterone) is a progestogen that has


    high specific affinity for progesterone receptors, no affinity for androgen,
    mineralocorticoid, glucocorticoid, and estrogenic receptors.

     Both micronized progesterone and dydrogesterone are closely related to


    endogenous progesterone, both in its molecular structure as well in
    pharmacological effects.

     Progesterone is currently used in early pregnancy for various indications by


    oral, vaginal, IM route and as tablets, capsules, vaginal pessaries, injections
    and gels.

    3 | Page
    PROGESTERONE SUPPLEMENTATION FOR LUTEAL SUPPORT IN
    ASSISTED REPRODUCTIVE TECHNIQUES (ART)

     Luteal function is usually compromised in ART cycles both in GnRH


    agonist and antagonist protocol.
     Adequate luteal phase support is required during ART to improve
    implantation and pregnancy rates, which can be achieved by either hCG
    (human chorionic gonadotropin) or directly by using progesterone.
     Endogenous progesterone deficiency is responsible for implantation failure
    and early miscarriages.
     Progesterone supplementation is advisable starting just after Oocyte
    Retrieval/Embryo Transfer.
     The duration of exogenous progesterone therapy generally varies up to 10-
    12 weeks of gestation.
     The following are routes of administration and doses based on the currently
    available evidence on progesterone in ART cycles
    o Intramuscular progesterone: 50-100mg/day
    o Vaginal micronized progesterone: 600-800mg/day
    o Oral Dydrogesterone: 20-30mg/day
    o Vaginal progesterone Gel: 8% (90mg) once daily

    PROGESTERONE SUPPORT IN RECURRENT PREGNANCY LOSS


    AND THREATENED MISCARRIAGE

    4 | Page
     About 10% to 15% of the clinically recognizable pregnancies result in
    spontaneous miscarriages. Increase in the number of miscarriages would
    lead to an increase in the rate of subsequent miscarriage (13-17% after first
    miscarriage and 55% after the third miscarriage).
     Recurrent spontaneous miscarriage is spontaneous loss of 3 or more
    consecutive pregnancies before 20 weeks of gestation
     Threatened miscarriage is a pregnancy complicated by bleeding before 20
    weeks gestation.
     Inadequate secretion of endogenous progesterone in early pregnancy has
    been linked as one of the etiological factors for recurrent miscarriage.
     Progesterone induces secretory changes in the endometrium essential for
    endometrial maturation, endometrial stabilization and embryo implantation
    and proper regulation of inflammatory mediators to create adequate positive
    immune response in early pregnancy, preventing pregnancy loss.
     Dydrogesterone is known to have immunomodulatory properties such as
    decreasing pro-inflammatory and increasing anti-inflammatory cytokines in
    early pregnancy. 3,8,9
     A large multicenter study called PROMISE study
    (http://www.medscinet.net/promise) is currently underway to assess vaginal
    micronised progesterone supplementation in women with unexplained
    recurrent miscarriages.
     Similarly the world’s largest Phase III study called Lotus I and Lotus II is
    ongoing in several European, Middle East, Asian countries to assess the role
    of Dydrogesterone, Micronised Progesterone vaginal tablets and Micronised
    Progesterone gel as Progesterone support in Artificial Reproductive
    Techniques, including IVF.
     Based on the available clinical data, progesterone support (vaginal
    micronized progesterone & dydrogesterone) is beneficial in women

    5 | Page
    presenting with a clinical diagnosis of threatened miscarriage with relative
    risk reduction in the miscarriage rate of 47% with the use of progesterone
    (risk ratio (RR) 0.53; 95% confidence interval (CI) 0.35 to 0.79). 1,7
     The argument for use of progesterone (vaginal micronized progesterone &
    dydrogesterone) is that there is no evidence of harm and some evidence of
    benefit, although not coming from huge multicentric trials. The decision
    should be based on clinician's discretion until strong evidence is available to
    recommend routine use
     The doses of progesterone that are generally used in clinical practice as per
    current evidence are as follows:
     Recurrent Miscarriage:
    o Oral dydrogesterone 10 mg BD till 20 weeks of pregnancy
    o Micronized Progesterone : 400mg /day vaginally till 20 weeks of
    pregnancy

     Threatened Miscarriage :

    o Micronized Progesterone : 400mg /day vaginal till bleeding stops.

    o Dydrogesterone :40 mg loading dose followed by 20-30 mg daily till


    7 days after bleeding stops.
     There is no role of progesterone supplementation in normal healthy pregnant
    women for prevention of miscarriage.

    SAFETY OF PROGESTERONE

    6 | Page
     Available evidence strongly supports the safety of progesterone when used
    in pregnancy (based on the available clinical data on vaginal progesterone
    and dydrogesterone).
     There is no statistically significant difference in the congenital abnormalities
    seen in the clinical studies between the newborns of the mothers who
    received progesterone and those who did not.
     The adverse effects reported with oral progesterones are;
    o common adverse event: breast tenderness, bloating, headache,
    o other adverse events include: constipation/diarrhea, itching/urticarial
    rash, fatigue, irritability, anxiety/depression somnolence.
    o In addition, intramuscular progesterone adverse effects include
    redness at the injection site, pain and inflammation.
    o Transvaginal use of progesterone can cause discharge, vaginal
    irritation in some patients.
     Progesterone should be used with caution in patients with cardiovascular
    diseases and in patients with impaired liver function and cholestasis.

    References:

    1. Wahabi HA, Fayed AA, Esmaeil SA, Al Zeidan RA. Progestogen for treating threatened
    miscarriage. Cochrane Database of Systematic Reviews 2011, Issue 12. Art. No.:
    CD005943. DOI: 10.1002/14651858.CD005943.pub4.
    2. van der Linden M, Buckingham K, Farquhar C, Kremer JAM, Metwally M. Luteal phase
    support for assisted reproduction cycles. Cochrane Database of Systematic Reviews
    2011, Issue 10. Art. No.: CD009154. DOI: 10.1002/14651858.CD009154.pub2.
    3. Raghupathy R et al. Modulation of cytokine production by dydrogesterone in
    lymphocytes from women with recurrent miscarriage. BJOG: an International Journal of
    Obstetrics and Gynaecology 2005;112:1096-1101
    4. Kalinka J et al. AJRI 2005;53:166-171

    7 | Page
    5. Royal Australian and New Zealand College of Obstetricians and Gynaecologists
    (RANZCOG) 2013.
    http://www.ranzcog.edu.au/doc/progesterone-support-of-the-luteal-phase-and-early-
    pregnancy.html
    (Last accessed March 2014).
    6. Schindler AE. Progestational effects of dydrogesterone in vitro, in vivo and on the human
    endometrium. Maturitas 65S (2009) S3–S11
    7. Howard Carp et al; Gynecol Endocrinology, 2012; 28(12): 983-990
    8. Polgar Beata et al, Biology of Reproduction, 71, 1699-1705 (2004)
    9. Kelemen et al, American Journal of Reproductive Immunology, Vol 39, 1998

    8 | Page

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