Oral Versus Vaginal Progesterone in the Luteal Support in Cryo-warmed Embryo Transfer Cycles
Primary Purpose
Sterility, Infertility
Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Progesterone
Sponsored by
About this trial
This is an interventional treatment trial for Sterility focused on measuring Luteal Phase Support, Cryo-warmed Embryo Transfer, Assisted Reproductive Technology
Eligibility 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
Sites / Locations
- American University of Beirut Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Oral Dydrogesterone
Vaginal microprogesterone
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Live births per embryo transferred
Number of live births per number of embryos transferred
Secondary Outcome Measures
Ongoing or Clinical pregnancy rate per started treatment cycle (CPR)
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)
Number of intrauterine gestational sacs observed on transvaginal ultrasound divided by the number of transferred embryos
Miscarriage rates
Pregnancy loss prior to 12 weeks of gestation
Multiple gestation rate
More than one intra-uterine gestation sac at 6 weeks of gestation
Full Information
NCT ID
NCT03619707
First Posted
August 3, 2018
Last Updated
July 19, 2023
Sponsor
American University of Beirut Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03619707
Brief Title
Oral Versus Vaginal Progesterone in the Luteal Support in Cryo-warmed Embryo Transfer Cycles
Official Title
Oral Dydrogesterone Versus Vaginal Progesterone in the Luteal Phase Support in Cryo-warmed Embryo Transfer Cycles: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sterility, Infertility
Keywords
Luteal Phase Support, Cryo-warmed Embryo Transfer, Assisted Reproductive Technology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Dydrogesterone
Arm Type
Experimental
Arm Description
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.
Arm Title
Vaginal microprogesterone
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Progesterone
Intervention Description
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 Measure Information:
Title
Live births per embryo transferred
Description
Number of live births per number of embryos transferred
Time Frame
until date of delivery
Secondary Outcome Measure Information:
Title
Ongoing or Clinical pregnancy rate per started treatment cycle (CPR)
Description
The presence of a viable fetus at 20 weeks gestation or fetal heart beat on transvaginal ultrasound after 6-7 weeks of gestation
Time Frame
20 weeks from Last Menstrual Period (LMP)
Title
Implantation rate (IR)
Description
Number of intrauterine gestational sacs observed on transvaginal ultrasound divided by the number of transferred embryos
Time Frame
7 weeks from LMP
Title
Miscarriage rates
Description
Pregnancy loss prior to 12 weeks of gestation
Time Frame
From a positive pregnancy test till 12 weeks gestation
Title
Multiple gestation rate
Description
More than one intra-uterine gestation sac at 6 weeks of gestation
Time Frame
6-7 weeks of gestation
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
American University of Beirut Medical Center
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
Learn more about this trial
Oral Versus Vaginal Progesterone in the Luteal Support in Cryo-warmed Embryo Transfer Cycles
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