Efficacy of Pergoveris in Aged IVF Patients

Vietnam National University

Status: Completed

Conditions: Infertility

Treatments: Drug: Follitropin alpha (FSH); Drug: Pergoveris (FSH and LH)

Study type: Interventional

Funder types: Other

Identifiers

NCT02244866

NCKH/CGRH_01_2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: Female

Ages: 35 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Pergoveris (FSH and LH)

Active Comparator group

Description:

150 IU of recombinant FSH and 75 IU of recombinant LH (Pergoveris) daily subcutaneous injection

Treatment:

Drug: Pergoveris (FSH and LH)

Follitropin alpha (FSH)

Active Comparator group

Description:

150 IU of recombinant FSH (follitropin alpha or Gonal-F) daily subcutaneous injection

Treatment:

Drug: Follitropin alpha (FSH)