Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

Phase 4

Terminated

Conditions: Infertility

Interventions: Drug: Crinone
Drug: Duphaston

Registration Number: NCT03858049

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary: 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 172

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crinone	Crinone	Participants received Crinone 8% (90 milligrams \[mg\] an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63.
Crinone plus Duphaston	Crinone	Participants received Crinone 8% (90 mg an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning followed by 10 mg of Duphaston tablet orally twice a day from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63.
Crinone plus Duphaston	Duphaston	Participants received Crinone 8% (90 mg an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning followed by 10 mg of Duphaston tablet orally twice a day from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63.

Primary Outcome Measures

Name	Time	Method
Ongoing Pregnancy Rate	8 to 10 weeks after embryo transfer	Ongoing pregnancy was assessed by the presence of viable intra uterine fetus detected by ultrasound examination in 10-12 weeks of pregnancy (8 to 10 weeks after embryo transfer). Ongoing pregnancy rate is defined as the number of participants with ongoing pregnancy divided by the number of participants with embryo transfer (ET) multiplied by 100.

Secondary Outcome Measures

Name	Time	Method
Early Abortion Rate	Time from embryo transfer to 12 weeks of pregnancy	Early abortion defined as the spontaneous loss of an intra-uterine pregnancy prior to 12 completed weeks of gestational age. Early abortion rate defined as the number of participants with early abortion divided by number of participants with clinical pregnancy multiplied by 100.
Vaginal Bleeding Rate	5 and 9 weeks after embryo transfer	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 participants with vaginal bleeding divided by number of participants with embryo transfer (ET) multiplied by 100.
Beta Human Chorionic Gonadotrophin (Beta-hCG) Positive Rate	2 weeks after embryo transfer	Beta-hCG positive rate defined as number of participants with positive beta-hCG divided by the number of participants with embryo transfer (ET) multiplied by 100.
Implantation Rate	4-6 weeks after embryo transfer	Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred (ET) multiplied by 100.
Clinical Pregnancy Rate	4-6 weeks after embryo transfer	Clinical Pregnancy was defined as the pregnancy diagnosed by ultrasound of one or more gestational sacs or definitive clinical signs of pregnancy. Clinical pregnancy rate was measured as the number of participants with clinical pregnancy divided by number of participants with embryo transfer (ET) multiplied by 100.
Luteal Phase Bleeding Rate	2, 5 and 9 weeks after embryo transfer	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 participants with Luteal phase bleeding divided by number of participants with embryo transfer (ET) multiplied by 100.