A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)

NCT ID: NCT01081652

Last Updated: 2014-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2005-05-31

Brief Summary

This was an open-label, randomized, comparative, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular (i.m.) administered once a day in luteal phase support in 200 Chinese female subjects undergoing IVF/ET.

Detailed Description

This was an open-label, randomized, comparative, multicentric, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular administered once a day in luteal phase support in Chinese female subjects undergoing IVF/ET. The study planned to enroll 200 female subjects who underwent pituitary down-regulation as per each center's normal practice prior to and during stimulation of multiple follicular development. The progesterone administration was started on the day of ET. Randomisation was performed on the day of ET. If pregnancy was confirmed on day 14 of the progesterone administration, the progesterone was continued for another 45 days. The subjects were followed up and the treatment outcome (negative pregnancy test or pregnancy) was recorded.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Crinone 8% group

Female subjects undergoing IVF/ET treated with Crinone 8% intravaginally

Group Type: EXPERIMENTAL

Micronised Progesterone

Intervention Type: DRUG

Micronised progesterone administered intravaginally once daily from the day of ET. If pregnancy was confirmed on day 14 of progesterone administration, progesterone was continued for another 45 days.

Intramuscular progesterone group

Female subjects undergoing IVF/ET treated with 60 mg progesterone intramuscularly once daily

Group Type: ACTIVE_COMPARATOR

Progesterone

Intervention Type: DRUG

Progesterone 60 mg administered intramuscular once daily from the day of ET. If pregnancy was confirmed on day 14 of progesterone administration, progesterone was continued for another 45 days.

Interventions

Micronised Progesterone

Micronised progesterone administered intravaginally once daily from the day of ET. If pregnancy was confirmed on day 14 of progesterone administration, progesterone was continued for another 45 days.

Intervention Type: DRUG

Progesterone

Progesterone 60 mg administered intramuscular once daily from the day of ET. If pregnancy was confirmed on day 14 of progesterone administration, progesterone was continued for another 45 days.

Intervention Type: DRUG

Other Intervention Names

Crinone 8%

Eligibility Criteria

Inclusion Criteria

• Patient has given written informed consent
• BMI < 25 kg/m2
• Age < 36 years
• <3 prior ART cycles (IVF, ICSI and related procedures)
• Infertility
• Regular spontaneous ovulatory menstrual cycles

Exclusion Criteria

• Habitual abortion
• Hydrosalpinges
• History of past poor response to COH
• Patients with serious arterial, lung, hepatic and renal diseases
• Hepatic and renal impairment

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Serono Singapore, an affiliate of Merck KGaA, Darmstadt, Germany.

Principal Investigators

Huafei Li

Role: STUDY_DIRECTOR

Serono Pharmaceutical Limited

Locations

Peking University 3rd Hopistal

Beijing, , China

Countries

China

Other Identifiers

IMP 25347

Identifier Type: -

Identifier Source: org_study_id