Comparing the Efficacy of Urinary and Recombinant Human Chorionic Gonadotropin (hCG) on Oocyte Maturity
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
In Vitro Fertilization |
Drug: recombinant hCG Drug: urinary hCG |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparing the Efficacy of Urinary and Recombinant hCG on Oocyte Maturity for Ovulation Induction in Assisted Reproductive Techniques: a Randomized Clinical Trial |
- Number of mature oocytes [ Time Frame: Up to1 hour after oocyte retrieval ] [ Designated as safety issue: Yes ]evaluation the effect of recombinant hcg on number of oocytes up to 1 hour after oocytes retrieval
- number of retrieved oocytes per number of aspirated follicles proportion [ Time Frame: up to 1 hour after oocyte retrieval ] [ Designated as safety issue: Yes ]Evaluation the effect of recombinant hCG to retrieve oocytes per number of aspirated follicles proportion
- fertilization rate [ Time Frame: in 1 day after oocyte retrieval ] [ Designated as safety issue: Yes ]Evaluation the effect of recombinant hCG on fertilization rate in 1 day after oocyte retrieval
- implantation rate [ Time Frame: 4 weeks after embryo transfer ] [ Designated as safety issue: Yes ]Evaluation the effect of recombinant hCG on implantation rate 4 weeks after embryo transfer
- OHSS occurrence rate will be compared between three groups [ Time Frame: from embryo transfer day up to pregnancy test ] [ Designated as safety issue: Yes ]Evaluation the effect of recombinant hCG on OHSS occurrence rate will be compared between three groups
- chemical pregnancy rates [ Time Frame: 2 weeks after embryo transfer ] [ Designated as safety issue: Yes ]Evaluation the effect of recombinant hCG on chemical pregnancy rates 2 weeks after embryo transfer
- clinical pregnancy rates [ Time Frame: 4 weeks after embryo transfer ] [ Designated as safety issue: Yes ]Evaluation the effect of recombinant hCG on clinical pregnancy rates 4 weeks after embryo transfer
| Estimated Enrollment: | 180 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | February 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A: recombinant hCG(250 µg Ovitrell)
1- Group A consisted of 60 infertile women who received recombinant hCG(250 µg Ovitrelle)
|
Drug: recombinant hCG
recombinant hCG(250 µg Ovitrell)
|
|
Experimental: B: recombinant hCG(500 µg Ovitrell)
2- Group B consisted of 60 infertile women who received recombinant hCG(500 µg Ovitrelle)
|
Drug: recombinant hCG
recombinant hCG(500 µg Ovitrell)
|
|
Experimental: C: urinary hCG
3- Group C consisted of 60 infertile patients received 10,000 IU urinary hCG
|
Drug: urinary hCG
10,000 IU urinary hCG
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 37 Years |
| Genders Eligible for Study: | 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
Contacts and Locations| Contact: Nasser Aghdami, MD,PhD | (+98)2122339913 | nasser.aghdami@royaninstitute.org |
| Contact: Leila Arab, MD | (+98)2122339951 | leila.arab@yahoo.com |
| Iran, Islamic Republic of | |
| Royan Institute | Recruiting |
| Tehran, Iran, Islamic Republic of | |
| Contact: Nasser Aghdami, MD,PhD (+98)2122339913 nasser.aghdami@royaninstitute.org | |
| Contact: Leila Arab, MD (+98)2122339951 leila.arab@yahoo.com | |
| Principal Investigator: Ladan Mohammadi Yeganeh, MSc | |
| Sub-Investigator: Nargess Bagheri Lankarani, PhD | |
| Sub-Investigator: zahra Ezabadi, MSc | |
| Sub-Investigator: Leili Karimian, MSc | |
| Sub-Investigator: Fatemeh Hassani, MSc | |
| Study Chair: | Hamid Gourabi, PhD | Head of Royan Institute |
| Study Director: | Taraneh Madani, MD | gynecology scientist |
| Principal Investigator: | Ladan Mohmmadi yeganeh, MSc | Investigator |
More Information
Additional Information:
No publications provided by Royan Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Royan Institute |
| ClinicalTrials.gov Identifier: | NCT01507376 History of Changes |
| Other Study ID Numbers: | Royan-Emb-012 |
| Study First Received: | September 14, 2011 |
| Last Updated: | January 5, 2012 |
| Health Authority: | Iran: Ethics Committee Iran: Ministry of Health |
Keywords provided by Royan Institute:
|
Ovulation induction urinary hCG recombinant hCG |
Additional relevant MeSH terms:
|
Chorionic Gonadotropin Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013