Condition category
Pregnancy and Childbirth
Date applied
22/05/2008
Date assigned
23/06/2008
Last edited
23/06/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ulun Ulug

ORCID ID

Contact details

Alman Hastanesi
Sýraselviler Cad No 117
Istanbul
80200
Turkey
ulunulug@superonline.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00677573

Protocol/serial number

N/A

Study information

Scientific title

Comparison of efficiency of recombinant follicle stimulating hormone (rec-FSH) and highly purified urinary follicle stimulating hormone (FSH) among women undergoing assisted reproductive treatment (ART)

Acronym

Study hypothesis

One of the most accepted patient friendly ovulation induction method for patients undergoing IVF seems to be protocols with gonadotropin-releasing hormone (GnRH) antagonist. Conceivably benefits of luteinising hormone (LH) activity and low cost may favor urinary gonadotropins.

Ethics approval

Ethics approval received from the Ethics Committee of the German Hospital in Istanbul on the 2nd May 2008 (ref: 17).

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Primary infertility

Intervention

Group A: starts with recombinant FSH (r-FSH)
Group B: starts with only urinary FSH (u-FSH)

In both groups GnRH antagonist will be initiated when leading follicle is 13 mm or on day 6 of stimulation.

Interventions:
Serum assays of baseline FSH, LH, oestrogen (E2), progesterone, testesterone on day 2 of cycle and serum assays of LH, E2, testosterone and progesterone on human chorionic gonadotropin (HCG) day and ovum pick-up (OPU) day.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Number of oocytes retrieved, 12 days following embryo transfer.

Secondary outcome measures

1. Pregnancy rate
2. Implantation rate
3. Duration of stimulation
4. Gonadotropin consumption

All secondary outcomes measured at 12 days following embryo transfer.

Overall trial start date

25/06/2008

Overall trial end date

30/11/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women less than 42 years old
2. Healthy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. Any of the ovary removed surgically
2. Surgically retrieved spermatozoa
3. FSH level over 13 mIU/ml

Recruitment start date

25/06/2008

Recruitment end date

30/11/2008

Locations

Countries of recruitment

Turkey

Trial participating centre

Alman Hastanesi
Istanbul
80200
Turkey

Sponsor information

Organisation

Bahceci Women Health Care Center (Turkey)

Sponsor details

Azer Is Merkezi 44-17
Abdi Ipekci Cad
Nisantasi
Isanbul
80200
Turkey
+90 (9)212 230 0809
mbahceci@superonline.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Bahceci Women Health Care Center (Turkey)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

German Hospital in Istanbul (Turkey)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes