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

Infertility Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081652
• Other study ID #: IMP 25347
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2010
• Last updated: July 30, 2014
• Start date: May 2004
• Est. completion date: May 2005

Study information

• Verified date: March 2010
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Peking University 3rd Hopistal	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in hCG positive rate in the two arms 14 days after embryo transfer			Yes
Primary	The difference in pregnancy rates in the two arms 30 and 60 days after embryo transfer			Yes
Primary	The difference in implantation rate in the two arms 30 days after embryo transfer			Yes