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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

Tracking Information
First Submitted Date  ICMJE August 3, 2018
First Posted Date  ICMJE August 8, 2018
Last Update Posted Date January 9, 2020
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
Live births per embryo transferred [ Time Frame: until date of delivery ]
Number of live births per number of embryos transferred
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • 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
  • 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
  • Miscarriage rates [ Time Frame: From a positive pregnancy test till 12 weeks gestation ]
    Pregnancy loss prior to 12 weeks of gestation
  • Multiple gestation rate [ Time Frame: 6-7 weeks of gestation ]
    More than one intra-uterine gestation sac at 6 weeks of gestation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Versus Vaginal Progesterone in the Luteal Support in Cryo-warmed Embryo Transfer Cycles
Official Title  ICMJE Oral Dydrogesterone Versus Vaginal Progesterone in the Luteal Phase Support in Cryo-warmed Embryo Transfer Cycles: Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sterility
  • Infertility
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Progesterone
  • 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
    Intervention: Drug: Progesterone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2018)
224
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 38 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Johnny Awwad, M.D 009613500 ext 5606 jawwad@aub.edu.lb
Listed Location Countries  ICMJE Lebanon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03619707
Other Study ID Numbers  ICMJE AmericanUBMC-CWET
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnny Awwad, American University of Beirut Medical Center
Study Sponsor  ICMJE American University of Beirut Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account American University of Beirut Medical Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP