Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 4

Conditions: Infertility

Treatments: Drug: Crinone; Drug: Duphaston

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03858049

MS200113_0005

Details and patient eligibility

About

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).

Enrollment: 172 patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

Crinone

Experimental group

Description:

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.

Treatment:

Drug: Crinone

Crinone plus Duphaston

Experimental group

Description:

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.

Treatment:

Drug: Duphaston

Drug: Crinone