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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) logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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