Clinical trial NCT01507376: Comparing the Efficacy of Urinary and Recombinant Human Chorionic Gonadotropin (hCG) on Oocyte Maturity
Official title: Comparing the Efficacy of Urinary and Recombinant hCG on Oocyte Maturity for Ovulation Induction in Assisted Reproductive Techniques: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: In Vitro Fertilization
Keywords: Ovulation induction
urinary
hCG
recombinant hCG
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2012-01-10
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. Group A consisted of 60 women who received recombinant hCG(250 µg Ovitrelle)
2. Group B consisted of 60 women who received recombinant hCG(500 µg Ovitrelle)
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of mature oocytes
timeFrame: Up to1 hour after oocyte retrieval
Secondary outcomes:
measure: number of retrieved oocytes per number of aspirated follicles proportion
timeFrame: up to 1 hour after oocyte retrieval
measure: fertilization rate
timeFrame: in 1 day after oocyte retrieval
measure: implantation rate
timeFrame: 4 weeks after embryo transfer
measure: OHSS occurrence rate will be compared between three groups
timeFrame: from embryo transfer day up to pregnancy test
measure: chemical pregnancy rates
timeFrame: 2 weeks after embryo transfer
measure: clinical pregnancy rates
timeFrame: 4 weeks after embryo transfer
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: gynecology scientist
name: Taraneh Madani, MD
role: STUDY_DIRECTOR
affiliation: Investigator
name: Ladan Mohmmadi yeganeh, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madani T, Mohammadi Yeganeh L, Ezabadi Z, Hasani F, Chehrazi M. Comparing the efficacy of urinary and recombinant hCG on oocyte/follicle ratio to trigger ovulation in women undergoing intracytoplasmic sperm injection cycles: a randomized controlled trial. J Assist Reprod Genet. 2013 Feb;30(2):239-45. doi: 10.1007/s10815-012-9919-3. Epub 2012 Dec 29.