DuoStim in Cases of PGT: Comparison of Embryo Quantity and Embryonic Quality Using MitoScore

• Status: Completed
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

Since preimplantation genetic testing (PGT) is being more frequently requested from patients as women pursue infertility treatments at an advanced age with a poorer prognosis, sometimes physicians are compelled to perform several stimulation cycles to obtain more eggs and, consequently, a greater number of biopsied embryos. Hence, the idea of carrying out this study arises as an attempt to optimize each menstrual cycle to the maximum.

It is believed that the double stimulation (DuoStim) protocol could be an alternative for this group of patients, allowing to obtain a larger number of oocytes in a shorter period, thus, increasing the number of biopsied embryos and possibly decreasing the interval to achieve a successful pregnancy.

The investigators aim to evaluate the potential usefulness of the DuoStim protocol for patients desiring to obtain oocytes as soon as possible. Using PGT, the investigators will compare the rate of euploid embryos per cycle in patients undergoing DuoStim protocol versus patients undergoing two conventional controlled ovarian hyperstimulation in consecutive cycles. Patients will include women with advanced age and poor response.

This is a unicentric, prospective, randomized, non-blind, parallel-group controlled phase IV clinical study. The investigators hypothesize that the rate of euploid embryos per cycle is similar in the DuoStim group compared to the group undergoing two conventional controlled ovarian hyperstimulation in consecutive cycles.

Furthermore the investigators will evaluate if there are differences regarding the number of total oocytes obtained, the number of mature oocytes, the number of biopsied blastocysts and the MitoScore index of the available euploid embryos.

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

Details

• Lead Sponsor: IVI Madrid
• Treatments: Cetrorelix; Ganirelix; Menotropins; Prolactin Release-Inhibiting Factors; Triptorelin Pamoate

Criteria

Inclusion Criteria:

• Signed informed consent;

• 35-42 years of age;

• Patients from the IVI Madrid undergoing controlled ovarian hyperstimulation cycle including PGT analysis for infertility treatment;

• BMI 18-30 kg/m2;

• Suspicion of suboptimal or poor response:

AMH < 1.5 ng/mL; AFC < 8; FSH > 10; Poor response in a previous cycle (defined as < 6 oocytes).

Exclusion Criteria:

• Simultaneous participation in another clinical trial or in any other study that could result in a confounding factor.