Efficacy of Pergoveris in Aged IVF Patients

December 23, 2014 updated by: Manh Tuong Ho, Vietnam National University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh, Vietnam
        • An Sinh Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pergoveris (FSH and LH)
150 IU of recombinant FSH and 75 IU of recombinant LH (Pergoveris) daily subcutaneous injection
Drug: Pergoveris (FSH and LH)
Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.
Other Names:
  • Pergoveris
Active Comparator: Follitropin alpha (FSH)
150 IU of recombinant FSH (follitropin alpha or Gonal-F) daily subcutaneous injection
Drug: Follitropin alpha (FSH)
Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.
Other Names:
  • Gonal-F

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy
Time Frame: 7 weeks after embryo transfer
Clinical pregnancy is defined by the image gestational sac under ultrasonography.
7 weeks after embryo transfer
Live birth
Time Frame: at the time of delivery
Live birth is defined if a live newborn delivered.
at the time of delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total FSH international units (IU) used for stimulation
Time Frame: Measure at the time when stimulation finishes, eg. in average 10-11 days, maximum 20 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vietnam National University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Estimate)

December 25, 2014

Last Update Submitted That Met QC Criteria

December 23, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCKH/CGRH_01_2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on Pergoveris (FSH and LH)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe