Desogestrel (DSG) and Corifollitropin(FSH-CTP) Alfa for Ovarian Stimulation in Donors

Infertility Clinical Trial

Official title:

Desogestrel and Corifollitropin Treatment for Ovarian Stimulation in Donors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02757287
• Other study ID #: SMD-DES-2016-01
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: September 2018
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently, controlled ovarian stimulation (COS) in oocyte donors is performed by daily injections of gonadotropins( recombinant FSH) plus a GnRH Antagonist usually form 5th-6th stimulation day until ovulation induction with a bolus of another injection of a gonadotropin-releasing hormone (GnRH) Agonist. Injections of the GnRH Antagonist avoid untimely luteinizing hormone (LH) surge and spontaneous ovulation prior to follicular aspiration. There is a preparation of long-acting recombinant follicle stimulating hormone (rFSH= (corifollitropin alfa (FSH-CTP), Elonva®, MSD), that allows that a single subcutaneous injection substitutes the first 7 days of daily gonadotropin injections. On the other hand, a contraceptive oral progesterone only( Desogestrel, DSG) is available for contraception, avoiding the LH surge. It has been described the usefulness of orally administered medroxyprogesterone acetate, 10 mg to inhibit the endogenous LH surge in IVF patients during COS.

In donors, by administering a single injection of FSH-CTP and oral desogestrel since the first menstruation day, the total number of injections administered is reduced and less discomfort is experienced without adverse impact on ovarian response. No description of the hormonal and ovarian response under this protocol has been published

Description:

• oral desogestrel since the first menstruation day,

• a single injection of FSH-CTP on the 7th menstrual cycle day

• routine monitoring of ovarian response with transvaginal ultrasound every second day until pre-ovulatory bolus of GnRH

• Hormones measured on day of 7th menstrual cycle day , day of pre-ovulatory bolus of GnRH and the day after the bolus ( estradiol, FSH, Progesterone, LH)

• Quality of Life questionnaire the day after the bolus

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2018
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Population: donors (18-35 ) from candidates of Donor program

• Fulfilling inclusión medical and legal criteria (RD -Ley de transposición de la normativa europea a la legislación española 9/2014)

• Who had had undergone previously convencional COS (controlled ovarian stimulation) with FSH-CTP and daily antagonist injections

• Given signed consent form.

Exclusion Criteria:

• Previous low response to COS

• Previous ovarian hyperstimulation syndrome.

• Ovarian cysts.

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• FSH-CTP + DESOGESTREL
Hormones measured on day of 7th menstrual cycle day , day of pre-ovulatory bolus of GnRH and the day after the bolus ( estradiol, FSH, Progesterone, LH) - Quality of Life questionnaire the day after the bolus

Locations

Country	Name	City	State
Spain	Hospital Quiron Dexeus	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Institut Universitari Dexeus	Fundación Dexeus Salud de la Mujer

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Martínez F, Boada M, Coroleu B, Clua E, Parera N, Rodríguez I, Barri PN. A prospective trial comparing oocyte donor ovarian response and recipient pregnancy rates between suppression with gonadotrophin-releasing hormone agonist (GnRHa) alone and dual suppression with a contraceptive vaginal ring and GnRH. Hum Reprod. 2006 Aug;21(8):2121-5. Epub 2006 Apr 21. — View Citation

Martínez F, Clua E, Santmartí P, Boada M, Rodriguez I, Coroleu B. Randomized, comparative pilot study of pituitary suppression with depot leuprorelin versus cetrorelix acetate 3 mg in gonadotropin stimulation protocols for oocyte donors. Fertil Steril. 2010 Nov;94(6):2433-6. doi: 10.1016/j.fertnstert.2010.02.059. Epub 2010 Apr 28. — View Citation

Requena A, Cruz M, Collado D, Izquierdo A, Ballesteros A, Muñoz M, García-Velasco JA. Evaluation of the degree of satisfaction in oocyte donors using sustained-release FSH corifollitropin a. Reprod Biomed Online. 2013 Mar;26(3):253-9. doi: 10.1016/j.rbmo.2012.11.015. Epub 2012 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total dose of gonadotrophins	Total Consume of gonadotrophins	At the end of the stimulation treatment period (5 or 7 days after begining of treatment)
Secondary	Plasma LH	Level of LH in plasma (mIU/ml)	Day of GnrH bolus
Secondary	Number of mature oocytes		Day of oocyte recovery

External Links

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