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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01081652

Enrollment

238

Registered

2010-03-05

Start date

2004-05-31

Completion date

2005-05-31

Last updated

2014-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Fertilisation, In vitro, Embryo transfer, progesterone, Reproductive technologies, Assisted

Brief 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.

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.

Interventions

DRUGMicronised 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.

DRUGProgesterone

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026