Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders

Launched by UNIVERSITY HOSPITAL, GHENT · Jul 22, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring two different approaches to help women who are expected to have a poor response to fertility treatments like IVF (in vitro fertilization). Researchers want to see if using a technique called Modified Natural Cycles (MNC) for up to three cycles is more effective than a single cycle using a medication called GnRH antagonist for these women. The goal is to find the best way to support those trying to conceive when they face challenges with their ovarian reserve, which refers to the number and quality of eggs in the ovaries.

To participate in the study, women must be between 18 and 45 years old and should have regular menstrual cycles. They should also have two ovaries and a desire to become pregnant, while meeting specific criteria that classify them as having a poor response to fertility treatments. Participants will be closely monitored throughout the trial, and they can expect to receive personalized care while contributing to important research that could help others in similar situations. It's important to note that women with certain medical conditions or those taking specific medications may not be eligible to join the study.

Gender

FEMALE

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.