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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02625519
Other study ID # BER-FSH-2015-01
Secondary ID 2015-003779-31
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 2015
Est. completion date March 2019

Study information

Verified date August 2018
Source Instituto Bernabeu
Contact Joaquín Llácer
Phone 965 154 000
Email jllacer@institutobernabeu.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Exploratory, prospective, randomized, comparative, open trial with control group treated to assess whether the effective use of urinary FSH (uFSH) or recombinant FSH (rFSH) can be influenced by genotype of receptor N680S FSH Gene Polymorphism.


Description:

The aim of this study is to determine whether the number of oocytes obtained in women oocyte donors may be different with the use of rFSH or uFSH based on receptor N680S FSHR gene polymorphism.

This is an exploratory, prospective, randomized, comparative, open trial with control group treated according to the usual therapeutic approach in our institution for ovarian stimulation for oocyte donors prospective exploratory study control group .

Three groups will be set based on follicle-stimulating hormone receptor (FSHR) genotype for the polymorphism N680: Group SS (Ser/Ser), group SN (Ser/Asn) and group NN (Asn/Asn). Donor members of each group will be randomly assigned to receive daily 225 IU of recombinant or urinary FSH for controlled ovarian stimulation protocol with antagonists. To avoid unintentional bias, allocation to treatment group will take place at the time in which ovarian stimulation according begins with a list of random allocation of treatments for each of the groups (SS , SN and NN) that will be associated the code of the patient and are prepared and will be available before the start of the study. The code assignment and treatment of the patient will consecutively in the order of the list and must be recorded in the medical history of the patient. The next scheduled patient will be assigned to the code and the next immediate treatment in this list.

The protocol for controlled ovarian stimulation in oocyte donors, will be performed always according to the usual protocol in the Instituto Bernabeu.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date March 2019
Est. primary completion date January 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- Be considered eligible to get into the oocyte donation program of Instituto Bernabeu

- Age between 18 and 30 years

- Body Mass Index over 18 and under 28

- Antral follicle count greater than 9 and less than 25 (adding both ovaries)

- Patients starting ovarian stimulation with 225 IU of FSH

- Presence of both ovaries

- Ability to participate and comply with the study protocol

- Signing the written consent form

- Not having received treatment with ovulation stimulators in the 3 months prior to stimulation

Exclusion Criteria:

- Not suitable for inclusion in the oocyte donation program of Institute Bernabeu

- Concurrent participation in another study

Study Design


Related Conditions & MeSH terms

  • Reproductive Techniques, Assisted

Intervention

Drug:
Urinary follicle-stimulating hormone
Ovarian stimulation with highly purified urinary follicle-stimulating hormone
Recombinant follicle-stimulating hormone
Controled ovarian stimulation with recombinant follicle-stimulating hormone

Locations

Country Name City State
Spain Instituto Bernabeu Alicante

Sponsors (1)

Lead Sponsor Collaborator
Instituto Bernabeu

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of cumulus-oocyte complexes obtained number of cumulus-oocyte complexes obtained by follicle puncture at the end of ovarian stimulation through study completion, an average of 2 weeks
Secondary number of metaphase II (MII) oocytes number of metaphase II (MII) oocytes obtained by follicle puncture at the end of ovarian stimulation through study completion, an average of 2 weeks
Secondary number of useful oocytes (inseminated or microinjected) number of useful oocytes after artificial insemination or microinjection through study completion, an average of 2 weeks
Secondary duration of stimulation (days) mean number of days between the start of ovarian stimulation until the day of the follicular puncture through study completion, an average of 2 weeks
Secondary FSH treatment units obtained by oocyte FSH treatment units administrated per oocyte obtained through study completion, an average of 2 weeks
Secondary FSH treatment cost per oocyte obtained FSH treatment cost per oocyte obtained through study completion, an average of 2 weeks
Secondary fertilization rate fertilization rate at 18 hours post-insemination through study completion, an average of 2 weeks
Secondary occurrence of side effects occurrence of side effects associated with urinary FSH and recombinant FSH through study completion, an average of 2 weeks
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