Clinical trial NCT04487925: Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders
Official title: A Randomized Comparison of One Controlled Ovarian Stimulation With Corifollitropin Alfa Versus up to Three Modified Natural Cycles in Expected and Established Poor Responders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ovarian Reserve
Poor Responders
IVF
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 208
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, single center, phase 4 controlled trial. The study will compare the efficacy of two different strategies for the management of predicted poor response patients under stimulation for IVF/ICSI: up to three MNC cycles (group 1) versus a single GnRH antagonist CFA (group 2).


Eligibility criteria: Inclusion Criteria:

* Informed consent form (ICF) dated and signed.
* Age ≥18 and \<45 years old.
* Body Mass Index (BMI) ≥18.5 Kg/m² and \<35 Kg/m².
* Regular menstrual cycles (between 21 and 35 days).
* Two ovaries present.
* Current pregnancy wish.
* Poor responders as defined according to the POSEIDON criteria:

POSEIDON Group 3: patients \< 35 years with poor ovarian reserve pre-stimulation parameters (AFC \<5 or AMH \<1.2 ng/mL); POSEIDON Group 4: patients ≥35 years with poor ovarian reserve pre-stimulation parameters (AFC \<5 or AMH \<1.2 ng/mL).

Exclusion Criteria:

* Simultaneous participation in another clinical study.
* Untreated and uncontrolled thyroid dysfunction.
* Tumors of the ovary, breast, uterus, pituitary or hypothalamus.
* Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
* Ovarian cysts or enlarged ovaries.
* Malformations of the reproductive organs.
* Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy.
* Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin).
* Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation.

Primary outcomes:
measure: Number of good quality blastocysts after CFA stimulation vs. after a first MNC
timeFrame: On fifth day of embryonal development
Secondary outcomes:
measure: Number of good quality blastocysts after CFA stimulation vs. after a second or third MNC
timeFrame: On fifth day of embryonal development
measure: The relative number of blastocysts after ART, relative to the number of oocytes
timeFrame: On fifth day of embryonal development
measure: The probability of having at least one blastocyst of good quality after ART
timeFrame: On fifth day of embryonal development
Other outcomes:
measure: The probability of having an ongoing pregnancy
timeFrame: 6 to 8 weeks gestational age
measure: The time until ongoing pregnancy
timeFrame: 6 to 8 weeks gestational age
Locations:
city: Gent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Dominic Stoop, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: