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Oral Versus Vaginal Progesterone in the Luteal Support in Cryo-warmed Embryo Transfer Cycles

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ClinicalTrials.gov Identifier: NCT03619707
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Johnny Awwad, American University of Beirut Medical Center

Brief Summary:

In IVF/ICSI cycles, the progesterone levels induced by ovarian stimulation are low, therefore the luteal phase is supported by progesterone. The use of progestogens in IVF is associated with an improvement in the live birth rate Standard protocol for luteal phase support has not yet been established. Currently vaginal progesterone is widely used, since the classic oral progesterone seems to result in a low bioavailability and a lower pregnancy rate. However, vaginal administration of progesterone is associated with vaginal irritation, discharge and bleeding. For all these reasons, there is a need for an effective, well tolerated, and safe treatment that can improve patient satisfaction and compliance.

Many studies have observed similar pregnancy rate results with dydrogesterone and micronized vaginal progesterone. A new RCT including a total of 1143 patients by Tournaye, showed that dydrogesterone treatment had a similar safety profile to micronized vaginal progesterone (MVP) for luteal support as part of ART treatment. The crude pregnancy rates at 12 weeks were 37.6% and 33.1% in the dydrogesterone and MVP treatment groups respectively.

Regarding the administration route of progesterone, intramuscular and transvaginal routes are the two conventional progesterone administration techniques. However, very few studies have compared the advantages of oral dydrogestrone with vaginal progesterone for luteal support in ART cycles.

The objective of the investigator's study is to demonstrate the superiority of oral dydrogesterone (Duphaston) 10 over MVP (Utrogestan) used for luteal supplementation in cryo-warmed embryo transfer cycles. Upon consent, 224 patients women will be randomly allocated into either one of the study groups using a simple randomization method by computer-generated random numbers. Group I will receive the oral dydrogesterone, while group II will receive the vaginal microprogesterone.


Condition or disease Intervention/treatment Phase
Sterility Infertility Drug: Progesterone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Dydrogesterone Versus Vaginal Progesterone in the Luteal Phase Support in Cryo-warmed Embryo Transfer Cycles: Randomized Controlled Trial
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral Dydrogesterone
Oral dydrogesterone (Duphaston 10 mg) will be given orally four times daily : will be continued till the pregnancy test, and till at least 12 weeks of gestation in case of a positive pregnancy test.
Drug: Progesterone
Patients will be randomly assigned during the treatment follow up, at the time of addition of progesterone to the regimen, following computerized random number generator in procedure, to one of the study groups. Patients will be aware of the allocated arm since the treatment drugs have different route of administration. Group I will receive the oral dydrogesterone, while group II will receive the vaginal microprogesterone.

Experimental: Vaginal microprogesterone
Vaginal progesterone (Utrogestan 200 mg) will be given vaginally four times daily: will be continued till the pregnancy test, and till at least 12 weeks of gestation in case of a positive pregnancy test
Drug: Progesterone
Patients will be randomly assigned during the treatment follow up, at the time of addition of progesterone to the regimen, following computerized random number generator in procedure, to one of the study groups. Patients will be aware of the allocated arm since the treatment drugs have different route of administration. Group I will receive the oral dydrogesterone, while group II will receive the vaginal microprogesterone.




Primary Outcome Measures :
  1. Live births per embryo transferred [ Time Frame: until date of delivery ]
    Number of live births per number of embryos transferred


Secondary Outcome Measures :
  1. Ongoing or Clinical pregnancy rate per started treatment cycle (CPR) [ Time Frame: 20 weeks from Last Menstrual Period (LMP) ]
    The presence of a viable fetus at 20 weeks gestation or fetal heart beat on transvaginal ultrasound after 6-7 weeks of gestation

  2. Implantation rate (IR) [ Time Frame: 7 weeks from LMP ]
    Number of intrauterine gestational sacs observed on transvaginal ultrasound divided by the number of transferred embryos

  3. Miscarriage rates [ Time Frame: From a positive pregnancy test till 12 weeks gestation ]
    Pregnancy loss prior to 12 weeks of gestation

  4. Multiple gestation rate [ Time Frame: 6-7 weeks of gestation ]
    More than one intra-uterine gestation sac at 6 weeks of gestation



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Normal uterine cavity
  • Normal Hormonal investigation: TSH,PRL,FBS
  • Frozen embryo transfer cycles: at least 2 embryos
  • Primary or secondary infertility: tubal occlusion, male factor, unexplained, endometriosis, ovarian factors…
  • Body mass index (BMI) ≥18 to ≤30 kg/m2

Exclusion Criteria:

  • Preexisting untreated medical condition (thyroid disease, diabetes mellitus, hypertension, pulmonary conditions, cardiac condition…)
  • History of three or more consecutively failed In Vitro Fertilization (IVF) cycles after embryo transfer
  • History of three or more miscarriages
  • Previous allergy reactions to progesterone products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619707


Contacts
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Contact: Johnny Awwad, M.D 009613500 ext 5606 jawwad@aub.edu.lb

Locations
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Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon
Contact: Johnny Awwad, MD    00961 1 350000 ext 5606    jawwad@aub.edu.lb   
Sponsors and Collaborators
American University of Beirut Medical Center
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Responsible Party: Johnny Awwad, Professor of Obstetrics and Gynecology, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03619707    
Other Study ID Numbers: AmericanUBMC-CWET
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Johnny Awwad, American University of Beirut Medical Center:
Luteal Phase Support
Cryo-warmed Embryo Transfer
Assisted Reproductive Technology
Additional relevant MeSH terms:
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Infertility
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs