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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 3

Conditions: Infertility

Treatments: Drug: Progesterone; Drug: Micronised Progesterone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01081652

IMP 25347

Details and patient eligibility

About

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.

Full 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.

Enrollment: 238 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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238 participants in 2 patient groups

Crinone 8% group

Experimental group

Description:

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

Treatment:

Drug: Micronised Progesterone

Intramuscular progesterone group

Active Comparator group

Description:

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

Treatment:

Drug: Progesterone