Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004328-73-ES

Enrollment

Unknown

Registered

2016-05-17

Start date

2016-05-24

Completion date

Unknown

Last updated

2016-06-13

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

Conditions

Infertility

Interventions

Trade Name: PROGEVERA Product Name: PROGEVERA Pharmaceutical Form: Tablet INN or Proposed INN: MEDROXYPROGESTERONE ACETATE Other descriptive name: MEDROXYPROGESTERONE ACETATE Concentration unit: mg mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Oocyte donors included in the oocyte donation program of Clinica EUGIN are healthy women younger than 35 years old with normal ovarian reserve. - 1st oocyte donation cycle at Clínica EUGIN. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Polycistic Ovarian syndrome (PCOs). - Estradiol levels on day 2 of menstrual cycle >70 pg/ml. - Hormone treatments up to 3 months before the oocyte donation cycle. - Medical contraindication to the treatments used in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the non-inferiority effect, and equal safety, of oral medroxiprogesterone acetate administered orally compared to GnRH antagonist on donor ovarian response.;Secondary Objective: To further evaluate the effect of medroxiprogesterone acetate on hormonal response, inhibition of the luteinizing hormone surge, embryological laboratory outcomes, reproductive outcomes in oocyte recipients and adverse events.;Primary end point(s): - Number of mature oocytes (MII) recovered at oocyte pick-up (OPU).;Timepoint(s) of evaluation of this end point: OPU day	—

Measure

Time frame

Main Objective: To evaluate the non-inferiority effect, and equal safety, of oral medroxiprogesterone acetate administered orally compared to GnRH antagonist on donor ovarian response.;Secondary Objective: To further evaluate the effect of medroxiprogesterone acetate on hormonal response, inhibition of the luteinizing hormone surge, embryological laboratory outcomes, reproductive outcomes in oocyte recipients and adverse events.;Primary end point(s): - Number of mature oocytes (MII) recovered at oocyte pick-up (OPU).;Timepoint(s) of evaluation of this end point: OPU day

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Secondary

Measure	Time frame
Secondary end point(s): Controlled ovarian stimulation outcome variables - Total gonadotropin dose (international units) - Duration of stimulation (days) - Serum hormone profiles (FSH, LH, E2 and P4) during ovarian stimulation, at trigger day and just before OPU. - LH premature surge (yes/no), defined as LH>11 during ovarian stimulation - Cancellation rate: number of patients who have stopped COS before OPU/total number of patients - Number of cumulus (COC) recovered at OPU - Ratio MII/COC Laboratory outcomes variables - Fertilization rate: number of oocytes fertilized/number of oocyte inseminated (%). - Embryo developmental score: qualification based on number of cells, symmetry, and percent of fragmentation in embryos (4-10 points). Pregnancy outcomes variables - Biochemical pregnancy: positive pregnancy test in blood performed 14 days after the embryo transfer. - Clinical pregnancy: fetal heart beat observed at 7th week of gestation. - Implantation: number of fetuses observed/number of embryos transferred.;Timepoint(s) of evaluation of this end point: OPU, day of ICSI and day of delivery (recipient).	—

Measure

Time frame

Secondary end point(s): Controlled ovarian stimulation outcome variables - Total gonadotropin dose (international units) - Duration of stimulation (days) - Serum hormone profiles (FSH, LH, E2 and P4) during ovarian stimulation, at trigger day and just before OPU. - LH premature surge (yes/no), defined as LH>11 during ovarian stimulation - Cancellation rate: number of patients who have stopped COS before OPU/total number of patients - Number of cumulus (COC) recovered at OPU - Ratio MII/COC Laboratory outcomes variables - Fertilization rate: number of oocytes fertilized/number of oocyte inseminated (%). - Embryo developmental score: qualification based on number of cells, symmetry, and percent of fragmentation in embryos (4-10 points). Pregnancy outcomes variables - Biochemical pregnancy: positive pregnancy test in blood performed 14 days after the embryo transfer. - Clinical pregnancy: fetal heart beat observed at 7th week of gestation. - Implantation: number of fetuses observed/number of embryos transferred.;Timepoint(s) of evaluation of this end point: OPU, day of ICSI and day of delivery (recipient).

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Countries

Spain

Contacts

Public ContactScientific Coordinator

Fundació Privada EUGIN

dgarcia@eugin.es0034933221122

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026