Comparing the Efficacy of Urinary and Recombinant hCG on Oocyte Maturity for Ovulation Induction in Assisted Reproductive Techniques: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Royan Institute
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Number of mature oocytes
Study Overview
Brief Summary
This study is a prospective randomized clinical trial to compare the efficacy of the urinary and recombinant hCG on oocyte quality for ovulation induction in women undergoing IVF/ICSI.
Detailed Description
The study population comprised of all infertile patients aged 20-37 years which underwent of in-vitro fertilization in royan institute, Tehran Iran.
In this study all patients were treated with a long stimulation protocol in which GnRH-analogue (Buserelin subcutaneous, 0.5cc daily) was given as a pre-treatment and recombinant FSH (rFSH) administration was started when pituitary desensitization was confirmed. From the 7th day of stimulation in both groups, daily monitoring of follicle size by ultrasound was performed and the dose of rFSH was adjusted according to the response of each patient. When at least two follicles > 18 mm diameter were seen, ovulation was triggered with hCG and patients allocated into three different study groups as per the following:
- Group A consisted of 60 women who received recombinant hCG(250 µg Ovitrelle)
- Group B consisted of 60 women who received recombinant hCG(500 µg Ovitrelle)
- Group C consisted of 60 patients received 10,000 IU urinary hCG Oocyte retrieval performed about 34-36 hours after hCG administration and then oocytes were assessed for nuclear maturity. Embryos transferred 2-3 days thereafter.
Data collection will be performed by using questionnaire to be filled as per the available records and laboratory results. Data analysis will be done through descriptive and perceptive statistical methods by using SPSS software version 16 for windows.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 37 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Indication for IVF/ICSI and Long Protocol ovarian stimulation
- •Age 20-37
- •Body mass index (BMI) ≤ 30 kg/m2
- •Regular menstrual cycles of 25-35 days
- •Tubal or male factor
- •Existence of both ovary and normal uterine cavity
- •Basal FSH≥10
- •Physical health
Exclusion Criteria
- •Poly Cystic Ovarian Syndrome patients
- •Contraindications of gonadotropins administration
- •Poor response to ovulation induction in recent cycle
Arms & Interventions
A: recombinant hCG(250 µg Ovitrell)
1- Group A consisted of 60 infertile women who received recombinant hCG(250 µg Ovitrelle)
Intervention: recombinant hCG (Drug)
B: recombinant hCG(500 µg Ovitrell)
2- Group B consisted of 60 infertile women who received recombinant hCG(500 µg Ovitrelle)
Intervention: recombinant hCG (Drug)
C: urinary hCG
3- Group C consisted of 60 infertile patients received 10,000 IU urinary hCG
Intervention: urinary hCG (Drug)
Outcomes
Primary Outcomes
Number of mature oocytes
Time Frame: Up to1 hour after oocyte retrieval
evaluation the effect of recombinant hcg on number of oocytes up to 1 hour after oocytes retrieval
Secondary Outcomes
- number of retrieved oocytes per number of aspirated follicles proportion(up to 1 hour after oocyte retrieval)
- fertilization rate(in 1 day after oocyte retrieval)
- implantation rate(4 weeks after embryo transfer)
- OHSS occurrence rate will be compared between three groups(from embryo transfer day up to pregnancy test)
- chemical pregnancy rates(2 weeks after embryo transfer)
- clinical pregnancy rates(4 weeks after embryo transfer)