Luteal phase ovarian stimulation with Follitropin delta and dydrogesterone

Luteal phase ovarian stimulation with Follitropin delta and dydrogesterone: a randomized cross over pilot trial - Lady De

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003049-37-BE

Enrollment

Registered

2022-10-04

Start date

2022-11-23

Completion date

Unknown

Last updated

2024-08-05

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

Conditions

Volutary women who wish to donate their oocytes

Interventions

Trade Name: Rekovelle Product Name: Follotropin delta Product Code: FE 999049 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: Follitropin delta CAS Number: 146479-7

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age from = 18 to = 36 years • Body mass Index (BMI) =18 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Contraindications to the use of gonadotropins • Endometriosis grade 3-4 • Patients with Anti-mullerian hormone (AMH) 5ng/ml (Fraissinet A et al, 2017) • Patients under contraception with hormonal intrauterine device (IUD) • Any untreated endocrine abnormality

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of FE 999049 on the number of cumulus-oocyte complexes (COCs) when a Primed Progestin Ovarian Stimulation (PPOS) protocol is associated to both conventional follicular phase stimulation and Luteal phase Ovarian Stimulation (LPOS) protocol in oocyte donors.;Secondary Objective: To determine whether LPOS using PPOS protocol has comparable outcomes to conventional follicular phase stimulation with PPOS protocol, in oocyte donors. ;Primary end point(s): total number of retrieved COCs ;Timepoint(s) of evaluation of this end point: Oocyte retrieval will take place 36h after triggering of final follicular maturation	—

Measure

Time frame

Main Objective: To evaluate the effect of FE 999049 on the number of cumulus-oocyte complexes (COCs) when a Primed Progestin Ovarian Stimulation (PPOS) protocol is associated to both conventional follicular phase stimulation and Luteal phase Ovarian Stimulation (LPOS) protocol in oocyte donors.;Secondary Objective: To determine whether LPOS using PPOS protocol has comparable outcomes to conventional follicular phase stimulation with PPOS protocol, in oocyte donors. ;Primary end point(s): total number of retrieved COCs ;Timepoint(s) of evaluation of this end point: Oocyte retrieval will take place 36h after triggering of final follicular maturation

—

Secondary

Measure	Time frame
Secondary end point(s): • Endocrine profile in both treatment groups • Consumption (mcg) of gonadotrophins • Duration of ovarian stimulation • Days of progestin use • Total number of MII oocytes ;Timepoint(s) of evaluation of this end point: • through study completion, an average of 1 year • 1-2 hours after oocyte retrieval]	—

Countries

Belgium

Contacts

Public ContactStudy Team - Brussels IVF

UZ Brussel

Studieverpleegkundigen_CRG@uzbrussel.be+3224776648

Outcome results

None listed

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