Comparison of two different drug protocols for ovarian stimulation in women with low egg reserve undergoing first attempt of in vitro fertilization

The use of GnRH antagonist versus co-flare protocol for women with low ovarian reserve undergoing first cycle of in vitro fertilization - GnRH-antagonist vs co-flare protocol for women of low ovarian reserve

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004824-39-GB

Enrollment

Registered

2014-06-09

Start date

2015-09-18

Completion date

Unknown

Last updated

2020-07-27

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

Conditions

response to ovarian stimulation in women with reduced ovarian reserve undergoing first cycle of in vitro fertilisaion. MedDRA version: 17.0 Level: PT Classification code 10056204 Term: In vitro fertilisation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Cetrotide Product Name: cetrotide® Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Cetrorelix acetate Concentration unit: mg milligram(s) Concentration type: no

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Women 23-39 years, with body mass index (BMI) of 19-30 Kg/m2, who are ready to start their first IVF treatment cycle with or without intracytoplasmic sperm injection (ICSI) and who have AMH between 3.08-21.97 pmol/L and day 2-4 serum FSH =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: • Previous controlled ovarian stimulation for IVF • Day 2-4 serum FSH levels = 15 iu/L • AMH > 21.97 or < 3.08 pmol/L • Known allergies to study medications • Recognised endocrine abnormalities of the hypothalamic pituitary axis such as hypogonadism and hyperprolactinaemia • Unsuitable for IVF/ICSI on welfare of the child assessment • Concurrent participation in another drug trial

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect of two different treatment protocols of ovarian stimulation for IVF on the number of eggs retrieved from women with low ovarian reserve undergoing their first IVF cycle: the co-flare protocol and the GnRH-antagonist protocol. ;Secondary Objective: To compare the effect of the two different protocols on the following outcomes: 1- Duration of gonadotrophins (FSH) stimulation (days) and amount of FSH units used. 2- Number of follicles = 14 mm on the day of hCG administration. 3- Number of mature oocytes retrieved. 4- Number of oocytes fertilized. 5- Number of embryos cleaved on day 2. 6- Percentage of women who had blastocyst transfer. 7- Number of frozen embryos 8- Implantation rate. 9- Clinical pregnancy and live birth rates. 10- Cycle cancellation rate;Primary end point(s): Number of oocytes retrieved ;Timepoint(s) of evaluation of this end point: At the time of egg collection procedure.	—

Measure

Time frame

Main Objective: To compare the effect of two different treatment protocols of ovarian stimulation for IVF on the number of eggs retrieved from women with low ovarian reserve undergoing their first IVF cycle: the co-flare protocol and the GnRH-antagonist protocol. ;Secondary Objective: To compare the effect of the two different protocols on the following outcomes: 1- Duration of gonadotrophins (FSH) stimulation (days) and amount of FSH units used. 2- Number of follicles = 14 mm on the day of hCG administration. 3- Number of mature oocytes retrieved. 4- Number of oocytes fertilized. 5- Number of embryos cleaved on day 2. 6- Percentage of women who had blastocyst transfer. 7- Number of frozen embryos 8- Implantation rate. 9- Clinical pregnancy and live birth rates. 10- Cycle cancellation rate;Primary end point(s): Number of oocytes retrieved ;Timepoint(s) of evaluation of this end point: At the time of egg collection procedure.

—

Secondary

Measure	Time frame
Secondary end point(s): 1- Duration of gonadotrophins (FSH) stimulation (days) and amount of FSH units used. 2- Number of follicles = 14 mm on the day of hCG administration. 3- Number of mature oocytes retrieved. 4- Number of oocytes fertilized. 5- Number of embryos cleaved on day 2. 6- Percentage of women who had blastocyst transfer. 7- Number of frozen embryos 8- Implantation rate. 9- Clinical pregnancy and live birth rates.;Timepoint(s) of evaluation of this end point: From the time of egg collection procedure the following time points will be assessed 1- Immediately after 2- Within five days 3- Two weeks 4- Six weeks 5- Nine months	—

Measure

Time frame

Secondary end point(s): 1- Duration of gonadotrophins (FSH) stimulation (days) and amount of FSH units used. 2- Number of follicles = 14 mm on the day of hCG administration. 3- Number of mature oocytes retrieved. 4- Number of oocytes fertilized. 5- Number of embryos cleaved on day 2. 6- Percentage of women who had blastocyst transfer. 7- Number of frozen embryos 8- Implantation rate. 9- Clinical pregnancy and live birth rates.;Timepoint(s) of evaluation of this end point: From the time of egg collection procedure the following time points will be assessed 1- Immediately after 2- Within five days 3- Two weeks 4- Six weeks 5- Nine months

—

Countries

United Kingdom

Outcome results

None listed

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