Efficacy of Pergoveris in Aged IVF Patients

Infertility Clinical Trial

Official title:

A Randomized Controlled Trial to Compare the Efficacy Between Pergoveris and Follitropin Alfa in Ovarian Stimulation in Patients Aged ≥ 35 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244866
• Other study ID #: NCKH/CGRH_01_2012
• Status: Completed
• Phase: N/A
• First received: September 16, 2014
• Last updated: December 23, 2014
• Start date: October 2012
• Est. completion date: June 2014

Study information

• Verified date: December 2014
• Source: Vietnam National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Vietnam National University HCMC School of Medicine
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment.

Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH supplementation) for ovarian stimulation in aged IVF patients.

Description:

A randomized controlled single center study.

Based on the difference of 19.1% in the clinical pregnancy rate between the two treatment groups, with and without LH supplementation, in a previous study, with 90% power and a 2-sided P-value of 0.05, the number of subjects required was 109 per group (total 218). The recruitment target was 120 subjects per group (total 240) to allow for dropouts.

Eligible subjects were randomized in blocks of 4 via a computer generated random number list to either the Pergoveris arm or the follitropin alpha arm.

Ovarian stimulation was performed by using GnRH antagonist protocol.

Follitropin alfa (recombinant FSH) was administered on day 2 or day 3 of the menstrual cycle. The first FSH dose was determined according to each individual patient, based on the process as follows:

• AFC ≤ 6: 300 IU/day

• AFC 7-15: 225 IU/day

• AFC ≥ 16: 150 IU/day

GnRH antagonist (Cetrotide, Merck-Serono) was administered on day 5 of FSH administration.

• Recombinant LH (in the form of Pergoveris) was supplemented from day 6 of FSH administration. Patients in the Pergoveris group would be administered a reduced dose of recombinant FSH (reduced by 150 IU/day) which was replaced with Pergoveris (150IU FSH + 75IU LH)/day.

• The Follitropin alpha group retained recombinant FSH. In both groups, if the number of developing follicles was inappropriate, the dose could be titrated depending on the physician's judgment.

Monitoring the follicular development was performed by vaginal ultrasound probe, quantifying LH, estradiol and progesterone, starting from day 5 of FSH, based on the current processes of the hospital.

OPU and embryo transfer: OPU was performed 36 hours after hCG administration. Embryos were transferred on day 2.

Luteal phase support: daily vaginal progesterone

Pregnancy testing and ultrasound: a pregnancy test was done 14 days after embryo transfer. Beta hCG > 5mIU/ml was considered positive. Fetal ultrasound was performed 3 weeks after a positive pregnancy test to verify clinical pregnancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

Inclusion Criteria:

• age = 35 years

• body mass index <28 kg/m2

• had = 3 previous IVF attempts

• receiving a GnRH-antagonist protocol

• agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.

• have given written informed consent with the understanding that the subject may withdraw consent at any time

Exclusion Criteria:

• participating in another interventional clinical trial

• PCOS or WHO group 1

• have uterine abnormalities

• have endocrine disorders such as hyperprolactinemia, thyroid disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Pergoveris (FSH and LH)
Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.
• Follitropin alpha (FSH)
Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.

Locations

Country	Name	City	State
Vietnam	An Sinh Hospital	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Vietnam National University

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy	Clinical pregnancy is defined by the image gestational sac under ultrasonography.	7 weeks after embryo transfer	No
Primary	Live birth	Live birth is defined if a live newborn delivered.	at the time of delivery	No
Secondary	Total FSH international units (IU) used for stimulation	Calculate total number of IU of FSH used for stimulation at the last day of stimulation regime.	Measure at the time when stimulation finishes, eg. in average 10-11 days, maximum 20 days	No