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

Primary Purpose

Infertility

Status
Withdrawn
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
FSH-CTP + DESOGESTREL
Sponsored by
Institut Universitari Dexeus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Ovarian stimulation, LH inhibition

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Quiron Dexeus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FSH-CTP + DESOGESTREL

Arm Description

Single injection of FSH-CTP and oral desogestrel since the first menstruation day, until bolus of GnRH agonist to follicular maturation

Outcomes

Primary Outcome Measures

Total dose of gonadotrophins
Total Consume of gonadotrophins

Secondary Outcome Measures

Plasma LH
Level of LH in plasma (mIU/ml)
Number of mature oocytes

Full Information

First Posted
April 25, 2016
Last Updated
September 3, 2018
Sponsor
Institut Universitari Dexeus
Collaborators
Fundación Dexeus Salud de la Mujer
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1. Study Identification

Unique Protocol Identification Number
NCT02757287
Brief Title
Desogestrel (DSG) and Corifollitropin(FSH-CTP) Alfa for Ovarian Stimulation in Donors
Official Title
Desogestrel and Corifollitropin Treatment for Ovarian Stimulation in Donors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of financial support
Study Start Date
May 2016 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
December 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut Universitari Dexeus
Collaborators
Fundación Dexeus Salud de la Mujer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Ovarian stimulation, LH inhibition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FSH-CTP + DESOGESTREL
Arm Type
Experimental
Arm Description
Single injection of FSH-CTP and oral desogestrel since the first menstruation day, until bolus of GnRH agonist to follicular maturation
Intervention Type
Drug
Intervention Name(s)
FSH-CTP + DESOGESTREL
Intervention Description
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
Primary Outcome Measure Information:
Title
Total dose of gonadotrophins
Description
Total Consume of gonadotrophins
Time Frame
At the end of the stimulation treatment period (5 or 7 days after begining of treatment)
Secondary Outcome Measure Information:
Title
Plasma LH
Description
Level of LH in plasma (mIU/ml)
Time Frame
Day of GnrH bolus
Title
Number of mature oocytes
Time Frame
Day of oocyte recovery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Quiron Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
16632462
Citation
Martinez F, Boada M, Coroleu B, Clua E, Parera N, Rodriguez 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. doi: 10.1093/humrep/del121. Epub 2006 Apr 21.
Results Reference
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PubMed Identifier
20430379
Citation
Martinez F, Clua E, Santmarti 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.
Results Reference
background
PubMed Identifier
23352098
Citation
Requena A, Cruz M, Collado D, Izquierdo A, Ballesteros A, Munoz M, Garcia-Velasco JA. Evaluation of the degree of satisfaction in oocyte donors using sustained-release FSH corifollitropin alpha. Reprod Biomed Online. 2013 Mar;26(3):253-9. doi: 10.1016/j.rbmo.2012.11.015. Epub 2012 Dec 5.
Results Reference
background
Links:
URL
http://www.dexeus.com/
Description
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Desogestrel (DSG) and Corifollitropin(FSH-CTP) Alfa for Ovarian Stimulation in Donors

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