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

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01081652
First received: March 4, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: Micronised Progesterone
Drug: Progesterone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • The difference in hCG positive rate in the two arms 14 days after embryo transfer [ Designated as safety issue: Yes ]
  • The difference in pregnancy rates in the two arms 30 and 60 days after embryo transfer [ Designated as safety issue: Yes ]
  • The difference in implantation rate in the two arms 30 days after embryo transfer [ Designated as safety issue: Yes ]

Enrollment: 238
Study Start Date: May 2004
Study Completion Date: May 2005
Arms Assigned Interventions
Experimental: Crinone 8% group
Female subjects undergoing IVF/ET treated with Crinone 8% intravaginally
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.
Other Name: Crinone 8%
Active Comparator: Intramuscular progesterone group
Female subjects undergoing IVF/ET treated with 60 mg progesterone intramuscularly once daily
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.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081652

Locations
China
Peking University 3rd Hopistal
Beijing, China, 100191
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Huafei Li Serono Pharmaceutical Limited
  More Information

No publications provided

Responsible Party: Medical Director, Serono Singapore, an affiliate of Merck KGaA, Darmstadt, Germany.
ClinicalTrials.gov Identifier: NCT01081652     History of Changes
Other Study ID Numbers: IMP 25347
Study First Received: March 4, 2010
Last Updated: March 4, 2010
Health Authority: China: Ministry of Health

Keywords provided by Merck KGaA:
Fertilisation, In vitro
Embryo transfer
progesterone
Reproductive technologies, Assisted

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014