A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)
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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) |
- 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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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 October 17, 2012