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

Desogestrel and Corifollitropin Treatment for Ovarian Stimulation in Donors

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02757287
Enrollment
0
Registered
2016-05-02
Start date
2016-05-31
Completion date
2018-12-01
Last updated
2018-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Ovarian stimulation, LH inhibition

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

Interventions

DRUGFSH-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

Sponsors

Fundación Dexeus Salud de la Mujer
CollaboratorUNKNOWN
Fundacion Dexeus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Total dose of gonadotrophinsAt the end of the stimulation treatment period (5 or 7 days after begining of treatment)Total Consume of gonadotrophins

Secondary

MeasureTime frameDescription
Number of mature oocytesDay of oocyte recovery
Plasma LHDay of GnrH bolusLevel of LH in plasma (mIU/ml)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026