Does prolonged downregulation prior to ART improve the clinical pregnancy rate in postoperative endometriosis patients? A RCT

Does prolonged GnRH downregulation prior to ART improve the clinical pregnancy rate in postoperative endometriosis patients? A RCT - Ultralong Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000993-32-BE

Enrollment

172

Registered

2013-03-27

Start date

2013-05-07

Completion date

Unknown

Last updated

2018-04-30

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

Conditions

endometriosis, subfertility MedDRA version: 15.1 Level: LLT Classification code 10042392 Term: Subfertility (female) System Organ Class: 100000004872 MedDRA version: 15.1 Level: LLT Classification code 10014789 Term: Endometriosis, site unspecified System Organ Class: 100000004872

Interventions

Trade Name: Decapeptyl 3,75mg Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: TRIPTORELIN ACETATE CAS Number: 140194-24-7 Concentration unit: mg/ml milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: History of endometriosis surgery Indications for ART (Tubal transport problems, failed IUI and/or spontaneous approach, severe male factor infertility) Age maximum 39 y (inclusive) at randomization First three ART cycles Normal uterine cavity Day 2-5 FSH =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ICSI-cryo-TESE for non-obstructive azoospermia, PGD or PGS History of poor ovarian response in previous ART (<4 oocytes)

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The rate of clinical pregnancy with positive fetal heart beat (CPHB) after ART ;Timepoint(s) of evaluation of this end point: hCG serum pregnancy test at 2-3 weeks after embryo transfer; in case of pregnancy: ultrasound at 7-8 weeks of pregnancy;Main Objective: To assess the contribution of prolonged (3months) treatment with GnRH agonists after endometriosis surgery and before ART (Assisted Reproductive Technology: IVF and ICSI) to the clinical pregnancy rate using ART.;Secondary Objective: ART parameters (ovarian response, embryo quality, gonadotrophin use, implantation rate, OHSS etc.), live birth, pain at egg aspiration, cumulative pregnancy rate (including frozen/thawed ET)	—

Measure

Time frame

Primary end point(s): The rate of clinical pregnancy with positive fetal heart beat (CPHB) after ART ;Timepoint(s) of evaluation of this end point: hCG serum pregnancy test at 2-3 weeks after embryo transfer; in case of pregnancy: ultrasound at 7-8 weeks of pregnancy;Main Objective: To assess the contribution of prolonged (3months) treatment with GnRH agonists after endometriosis surgery and before ART (Assisted Reproductive Technology: IVF and ICSI) to the clinical pregnancy rate using ART.;Secondary Objective: ART parameters (ovarian response, embryo quality, gonadotrophin use, implantation rate, OHSS etc.), live birth, pain at egg aspiration, cumulative pregnancy rate (including frozen/thawed ET)

—

Secondary

Measure	Time frame
Secondary end point(s): ART parameters (ovarian response, embryo quality, gonadotrophin use, implantation rate, OHSS etc.), live birth, pain at egg aspiration, cumulative pregnancy rate (including frozen/thawed ET);Timepoint(s) of evaluation of this end point: During the ART cycle and in the weeks and months after the cycle (pregnancy tests 14 days after embryo transfer; ultrasounds in case of a pregnancy as in standard care protocols, report of the delivery)	—

Measure

Time frame

Secondary end point(s): ART parameters (ovarian response, embryo quality, gonadotrophin use, implantation rate, OHSS etc.), live birth, pain at egg aspiration, cumulative pregnancy rate (including frozen/thawed ET);Timepoint(s) of evaluation of this end point: During the ART cycle and in the weeks and months after the cycle (pregnancy tests 14 days after embryo transfer; ultrasounds in case of a pregnancy as in standard care protocols, report of the delivery)

—

Countries

Belgium

Contacts

Public ContactFertility Center

Universtiy Hospital Leuven

carla.tomassetti@uzleuven.be

Outcome results

None listed

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