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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081652
First Posted: March 5, 2010
Last Update Posted: July 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Merck KGaA
  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
Intervention Model: Parallel Assignment
Masking: None (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
  • 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 4, 2010
First Posted: March 5, 2010
Last Update Posted: July 31, 2014
Last Verified: March 2010

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