Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Controlled ovarian hyperstimulation (COH) is an important step during in vitro fertilization (IVF). Its aim optimally is to recruit 10-15 oocytes. When deciding on the actual treatment, different stimulation protocols, various stimulating agents and wide range of gonadotropin dose can one choose from. Prior to the decision on the actual stimulation protocol and gonadotropin (Gn) dose the patient's expected response to stimulation is assessed primarily using ovarian reserve markers. Most medications used during stimulation exert their effect in a dose-dependent manner hence with a higher Gn dose one would expect a better response, more oocytes. More oocytes could translate into more embryos and potentially a higher pregnancy rate. The currently available evidence however does not support this practice as RCTs have failed to show that the use of higher Gn dose results in higher pregnancy, live-birth rates. These studies however identified patients based on different criteria, compared different stimulation protocols and various Gn doses. There are only two RCTs that compared cumulative live birth rates (fresh + frozen embryo transfers) and they identified poor responders based on different criteria and used different drug regimens. Therefore, the aim of our study is to compare cumulative IVF clinical pregnancy rates using a lower and a higher gonadotropin dose among poor responders identified based on universally accepted criteria.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter Kovacs MD
• Treatments: Follicle Stimulating Hormone; Menotropins

Criteria

Inclusion Criteria:

• Expected poor responder based on:

1. AMH: 0.3-1.2 ng/ml or AFC <5,

2. AMH>1.2 ng/ml or AFC≥5 but the retrieval of ≤ 4 oocytes during previous IVF treatment.

• motile sperm with normal morphology obtained from the ejaculate of testicular biopsy

• no more than 3 previous failed IVF cycles (if the patient had 2 or more previous cycles cancelled for poor response she cannot be included)

• BMI: 18-35 kg/m2

• regular 24-35 day cycles

• intact uterine cavity

• indication for in vitro fertilisation treatment (tubal factor, male factor, low ovarian reserve, endometriosis, unexplained infertility)

• age 18-421 yrs

Exclusion Criteria:

• presence of hydrosalpinx

• positive HIV, hepatitis B, C screening tests

• planned preimplantation genetic testing of the embryos

• planned elective cryopreservation

• lack of consent

• not meeting the inclusion criteria