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

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.

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Key information

Conditions

Infertility Behavior Genital Diseases Helping Behavior Social Behavior Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Peking University 3rd Hopistal

Beijing, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micronised Progesterone

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.

Other names: Crinone 8%

Progesterone

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.

Primary outcomes

The difference in hCG positive rate in the two arms 14 days after embryo transfer
The difference in pregnancy rates in the two arms 30 and 60 days after embryo transfer
The difference in implantation rate in the two arms 30 days after embryo transfer

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

An Open, Randomized, Comparative, Phase III Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilization and Embryo Transfer (IVF/ET)

Important dates

Study start: 2004
Study completion: 2005
First posted: Mar 5, 2010
Registry last updated: Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed