Initiation of ovarian stimulation in the late follicular phase

Initiation of ovarian stimulation with recombinant-human FSH (Bemfola®) in the late follicular phase, a randomised controlled study. - Recombinant-human FSH (Bemfola®) in the late follicular phase

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-005005-12-BE

Enrollment

Registered

2018-05-08

Start date

2018-05-28

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Subfertility Oocyte donation MedDRA version: 20.0 Level: LLT Classification code 10042392 Term: Subfertility (female) System Organ Class: 100000004872 MedDRA version: 20.0 Level: PT Classification code 10053370 Term: Oocyte donation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Bemfola Product Name: Bemfola Product Code: EMEA/H/C/002615 Pharmaceutical Form: Injection INN or Proposed INN: Follitropin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age from 18 to 36 years • BMI 19 to 35 • Regular menstrual cycle length i.e. 24-35 days 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Contraindications to the use of gonadotropins • Patients with AMH 5ng/ml (Fraissinet A et al, 2017) • Endometriosis grade 3-4 • Oligo-amenorrhea • Any untreated endocrine abnormality

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the current study is to determine whether late follicular stimulation using recombinant-human FSH has comparable outcomes to treatment using recombinant-human FSH in early follicular phase in a flexible GnRH antagonist protocol, in oocyte donor patients. The primary objective is total number of mature oocytes retrieved after ovarian stimulation.; Secondary Objective: a. Endocrine profile in both treatment groups (pattern of follicular development) b. Consumption of gonadotrophins c. Number of days needed for ovarian stimulation d. Days of GnRH antagonist use e. Total number of oocytes frozen f. Fertilization rate g. Total embryo utilization rate ;Primary end point(s): Total number of COC retrieved after ovarian stimulation.; Timepoint(s) of evaluation of this end point: Q2/2018 start of data collection Q3/2018 first patient first treatment Q1/2019 end of data collection Q1/2019 study report	—

Measure

Time frame

Main Objective: The aim of the current study is to determine whether late follicular stimulation using recombinant-human FSH has comparable outcomes to treatment using recombinant-human FSH in early follicular phase in a flexible GnRH antagonist protocol, in oocyte donor patients. The primary objective is total number of mature oocytes retrieved after ovarian stimulation.; Secondary Objective: a. Endocrine profile in both treatment groups (pattern of follicular development) b. Consumption of gonadotrophins c. Number of days needed for ovarian stimulation d. Days of GnRH antagonist use e. Total number of oocytes frozen f. Fertilization rate g. Total embryo utilization rate ;Primary end point(s): Total number of COC retrieved after ovarian stimulation.; Timepoint(s) of evaluation of this end point: Q2/2018 start of data collection Q3/2018 first patient first treatment Q1/2019 end of data collection Q1/2019 study report

—

Secondary

Measure	Time frame
Secondary end point(s): a. Endocrine profile in both treatment groups b. Consumption (IU) of gonadotrophins c. Duration of ovarian stimulation d. Days of GnRH antagonist use e. Total number of oocytes frozen ; Timepoint(s) of evaluation of this end point: Q2/2018 start of data collection Q3/2018 first patient first treatment Q1/2019 end of data collection Q1/2019 study report	—

Countries

Belgium

Contacts

Public Contactstudy nurse

UZ Brussel

3224776648

Outcome results

None listed

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