The exogenous progesterone free luteal phase after GnRHa trigger – a randomized controlled pilot study in normo-responder IVF patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000447-32-DK

Enrollment

100

Registered

2014-03-31

Start date

2014-04-23

Completion date

Unknown

Last updated

2020-11-09

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

Conditions

Infertility MedDRA version: 17.0 Level: LLT Classification code 10016398 Term: Female infertility System Organ Class: 100000004872

Interventions

Trade Name: Pregnyl Product Name: Pregnyl Product Code: 2830 Pharmaceutical Form: Concentrate for solution for injection CAS Number: 9002-61-3 Other descriptive name: CHORIONIC GONADOTROPIN Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria will be age between 20 and 40 years either normal menstrual cycles 25-34 days or oligomenorrhea/amenorrhea or polycystic syndrome (defined according to the Rotterdam criteria 2004). BMI >18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with >14 follicles on day of trigger Previous hyper response with OHSS development, previous low response (less than 3 oocytes on a high dose of FSH stimulation) and endocrine disorders

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this pilot RCT is to explore the exogenous progesterone-free luteal phase support after GnRHa trigger in a population of IVF patients without imminent risk of OHSS development compared with a control group who will receive hCG. The primary end-point will be the reproductive outcome defined as the ongoing pregnancy rate per patient at 10th week of gestation. ;Secondary Objective: The secondary end-points are the mid-luteal progesterone level, the correlation between mid-luteal progesterone levels and the reproductive outcome, and the OHSS rate.;Primary end point(s): Study group: 1.500 IU hCG on day of oocyte retrieval and an additional bolus of 1.000 IU hCG on day of oocyte retrieval +4 days Control group: Micronized vaginal progesterone and estradiol applied once daily until 7 weeks (42 days) of pregnancy. ;Timepoint(s) of evaluation of this end point: Blood samples to be collected on 1)day of triggering final maturation, 2)OPU+7, 3) ET+12-14day (at pregnancy test)	—

Measure

Time frame

Main Objective: The objective of this pilot RCT is to explore the exogenous progesterone-free luteal phase support after GnRHa trigger in a population of IVF patients without imminent risk of OHSS development compared with a control group who will receive hCG. The primary end-point will be the reproductive outcome defined as the ongoing pregnancy rate per patient at 10th week of gestation. ;Secondary Objective: The secondary end-points are the mid-luteal progesterone level, the correlation between mid-luteal progesterone levels and the reproductive outcome, and the OHSS rate.;Primary end point(s): Study group: 1.500 IU hCG on day of oocyte retrieval and an additional bolus of 1.000 IU hCG on day of oocyte retrieval +4 days Control group: Micronized vaginal progesterone and estradiol applied once daily until 7 weeks (42 days) of pregnancy. ;Timepoint(s) of evaluation of this end point: Blood samples to be collected on 1)day of triggering final maturation, 2)OPU+7, 3) ET+12-14day (at pregnancy test)

—

Secondary

Measure	Time frame
Secondary end point(s): Blood samples to be collected on 1) day of triggering final maturation 2) OPU+7 3) ET+12-14day (at pregnancy test);Timepoint(s) of evaluation of this end point: Blood samples to be collected on 1) day of triggering final maturation 2) OPU+7 3) ET+12-14day (at pregnancy test)	—

Countries

Denmark

Contacts

Public ContactPeter humaidan

Skive fertility clinic

peter.humaidan@viborg.rm.dk+4578445773

Outcome results

None listed

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