Comparing the Efficacy of Urinary and Recombinant Human Chorionic Gonadotropin (hCG) on Oocyte Maturity

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2010 by Royan Institute.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Royan Institute

ClinicalTrials.gov Identifier:

NCT01507376

First received: September 14, 2011

Last updated: January 5, 2012

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 14, 2011

Last Updated Date

January 5, 2012

Start Date ^ICMJE

October 2010

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01507376 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparing the Efficacy of Urinary and Recombinant Human Chorionic Gonadotropin (hCG) on Oocyte Maturity

Official Title ^ICMJE

Comparing the Efficacy of Urinary and Recombinant hCG on Oocyte Maturity for Ovulation Induction in Assisted Reproductive Techniques: a Randomized Clinical Trial

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

In Vitro Fertilization

Intervention ^ICMJE

Drug: recombinant hCG
recombinant hCG(250 µg Ovitrell)
Drug: recombinant hCG
recombinant hCG(500 µg Ovitrell)
Drug: urinary hCG
10,000 IU urinary hCG

Study Arm (s)

Experimental: A: recombinant hCG(250 µg Ovitrell)
1- Group A consisted of 60 infertile women who received recombinant hCG(250 µg Ovitrelle)

Intervention: Drug: recombinant hCG
Experimental: B: recombinant hCG(500 µg Ovitrell)
2- Group B consisted of 60 infertile women who received recombinant hCG(500 µg Ovitrelle)

Intervention: Drug: recombinant hCG
Experimental: C: urinary hCG
3- Group C consisted of 60 infertile patients received 10,000 IU urinary hCG

Intervention: Drug: urinary hCG

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

February 2012

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

20 Years to 37 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Nasser Aghdami, MD,PhD	(+98)2122339913	nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD	(+98)2122339951	leila.arab@yahoo.com

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01507376

Other Study ID Numbers ^ICMJE

Royan-Emb-012

Has Data Monitoring Committee

Yes

Responsible Party

Royan Institute

Study Sponsor ^ICMJE

Royan Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Hamid Gourabi, PhD	Head of Royan Institute
Study Director:	Taraneh Madani, MD	gynecology scientist
Principal Investigator:	Ladan Mohmmadi yeganeh, MSc	Investigator

Information Provided By

Royan Institute

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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