Efficacy of Low Dose hCG on Oocyte Maturity in Poor Responder Women Undergoing Intracytoplasmic Sperm Injection

Royan Institute

Status and phase: Completed; Phase 3

Conditions: Infertility

Treatments: Drug: rFSH; Drug: hCG

Study type: Interventional

Funder types: Other

Identifiers

NCT01509833

Royan-Emb-013

Details and patient eligibility

About

This study is a prospective, randomized, parallel, controlled trial to assess the efficacy of the late follicular phase administration of low dose hCG on oocyte maturity for ovarian stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (ICSI) treatment.

Full description

In this study all eligible patients were randomly allocated into three study groups by a permuted block randomization method: group A (control group) received only recombinant FSH, group B received rFSH supplemented by 100IU hCG in the late follicular phase. Group C received rFSH supplemented by 200IU hCG in the late follicular phase.

All of the patients underwent a standard long protocol and received GnRH-a (Suprefact), 0.5cc subcutaneous, started from the day 17 of the preceding cycle and ovulation induction was started 14 days thereafter.

Patients were categorized according to the following stimulation protocols:

Group A (control group): which 300 IU r-FSH was administered for the first 5 days of the stimulation cycle. Then the first ultrasound scan was performed to monitor response. At this stage the dose of rFSH adjusted according to the ovarian response and continued until the day of ovulatory hCG administration.

Group B: rFSH supplemented with daily administration of 100 IU hCG in the late follicular phase based on the follicle size (14mm).

Group C: rFSH supplemented with daily administration of 200 IU hCG in the late follicular phase based on the follicle size (14mm).

To assess the pregnancy outcomes, serum hCG was measured 2 weeks after embryo transfer. Clinical pregnancy was defined by the observation of sac with fetal heart rate on ultrasonography 4 weeks after embryo transfer.

Enrollment: 73 patients

Sex: Female

Ages: 37 to 43 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Poor ovarian response to ovulation induction according to the ESHRE definition[20] and presence of at least 2 of the criteria needed to define poor responders including advanced maternal age, history of low ovarian response in previous IVF/ICSI treatments and abnormal ovarian reserve test(Antral Follicle number < 5)
2. indication for ICSI treatment, second or third cycle
3. Age 37 to 43 years
4. Body mass index (BMI) ≤ 30 kg/m2
5. The presence of two functional ovaries and no previous ovarian surgery
6. The presence of normal uterine cavity and 2 normal tubes base on recent hysterosalpingographic or hysteroscopic evaluation
7. Basal (day 2 or 3) serum FSH levels ≤13 IU/L
8. Normal semen analysis
9. No history or signs of endometriosis
10. No untreated endocrinologic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 3 patient groups

rFSH

Experimental group

Description:

Administration of recombinant FSH for ovarian stimulation.

Treatment:

Drug: rFSH

hCG(100IU)

Experimental group

Description:

Administration of late follicular low dose hCG(100U) for ovarian stimulation.

Treatment:

Drug: hCG

Drug: hCG

hCG(200IU)

Experimental group

Description:

Administration of late follicular low dose hCG(200IU) for ovarian stimulation.

Treatment:

Drug: hCG

Drug: hCG