Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

Study Overview
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Brief Summary
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The study to compare to the efficacy and safety of Crinone versus combination medication in infertile women receive frozen-thawed embryo transfer (FET) in artificial cycles (AC).

Official Title
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Comparison of Crinone ® Versus Combination Medication for Luteal Phase Support on the Ongoing Pregnancy Rate of Frozen-thawed Cycle in Chinese Population a Randomized, Interventional, Open-label, Phase IV, Single Center, Pilot Study (ACCESS)

Conditions
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Infertility

Intervention / Treatment
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* Drug: Crinone
* Drug: Duphaston


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: Participants who will receive artificial frozen-thawed embryo transfer (FET) cycle study interventions Participants who have no more than two Day 5 embryos are planned to be transferred (follow the clinical practice of the study site) Participants have received estradiol valerate for no more than 20 days Participants have a transitional-endometrium of greater than or equal to 8 millimeter Participants have normal uterine cavity Participants can give signed informed consent Participants are willing to follow the study protocol and able to complete the study Exclusion Criteria: Participants are willing to follow the study protocol and able to complete the study Participants with greater than or equal to three previously failed cycles of ET Participants with diseases that cannot tolerate pregnancy Hydrosalpinx Severe endometriosis (Endometriosis American Society for Reproductive Medicine (ASRM) criteria from 1996) Known hypersensitivity to progesterone, the excipients of Crinone and Duphaston Vaginal bleeding of unknown origin History of recurrent miscarriages Vaginitis Thromboembolic diseases (thrombophlebitis, thromboembolic disorder, or cerebral apoplexy) or participants with a history of these conditions Known or suspected progestogen-dependent neoplasm Participation in another clinical trial within the past 30 days Contraindications of both Crinone and Duphaston

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crinone<br> | Drug: Crinone<br>* Participants will receive 90 milligram (mg) of intravaginal Crinone gel daily in the morning in the treatment period for approximately 75 days.<br>|
| Experimental: Crinone plus Duphaston<br> | Drug: Crinone<br>* Participants will receive 90 milligram (mg) of intravaginal Crinone gel daily in the morning in the treatment period for approximately 75 days.<br>Drug: Duphaston<br>* Participants will receive 10 mg of Duphaston orally twice a day in the treatment period for approximately 70 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing Pregnancy Rate | Ongoing pregnancy will be assessed by the presence of viable intra uterine fetus detected by ultrasound examination in 10-12 weeks of pregnancy. Ongoing pregnancy rate is defined as the number of ongoing pregnancies expressed per 100 embryo transfer cycles. | 8 to 10 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta Human Chorionic Gonadotrophin (Beta-hCG) Positive Rate | Beta-hCG positive rate defined as the number of Beta-hCG positive participants expressed per 100 embryo transfer cycles. | Day 14 | 
| Implantation Rate | The number of gestational sacs observed in ultrasound scan divided by the number of embryos transferred. | Day 35 | 
| Clinical Pregnancy rate | A pregnancy diagnosed by ultrasound of one or more gestational sacs or definitive clinical signs of pregnancy. Clinical Pregnancy rate defined as the number of clinical pregnancies expressed per 100 embryo transfer cycles. | Day 35 | 
| Number of Participants With Early Abortion | Early abortion defined as the spontaneous loss of an intra-uterine pregnancy prior to 12 completed weeks of gestational age. | Up to 12 Weeks | 
| Luteal Phase Bleeding Rate | Luteal Phase Bleeding defined as the onset of any bleeding after embryo transfer and prior to the pregnancy test. Luteal Phase Bleeding Rate defined as the number of the participants with luteal phase bleeding expressed per 100 embryos transferred cycles. | Up to Day 14 | 
| Vaginal Bleeding Rate | Vaginal bleeding is defined as any bleeding recorded after a pregnancy test via serum Beta-Human Chorionic Gonadotrophin. Vaginal bleeding rate defined as the number of the participants with vaginal bleeding expressed per 100 embryos transferred cycles. | Day 14 to Day 63 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frozen-thawed embryo transfer, Infertility, Crinone, Duphaston, Chinese population