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

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.

Conditions

• Infertility, Female

Interventions

DRUG

human menopausal gonadotropin

human menopausal gonadotropin subcutaneously

DRUG

GnRH antagonist

GnRH antagonist subcutaneously

DRUG

GnRH analog

GnRH analog subcutaneously

PROCEDURE

Trophectoderm biopsy

Trophectoderm biopsy is the process of removing few cells from an in vitro fertilization embryo.

DIAGNOSTIC_TEST

MitoScore

The cells removed from an in vitro fertilization embryo during the trophectoderm biopsy will be used to assess the mitochondrial DNA content as a viability indicator in the euploid embryos.

PROCEDURE

Intracytoplasmic sperm injection

ICSI is an in vitro fertilization procedure in which a single sperm is injected directly into an oocyte.

PROCEDURE

Ovarian puncture

Egg retrieval is a simple procedure. It is performed in an operating room for safety reasons. It is performed vaginally and involves aspirating the follicular fluid through a thin needle. Embryologists then retrieve from this fluid the eggs that have matured during stimulation. It lasts for 5 to 15 minutes, and a mild sedative is administered to prevent any kind of pain during the procedure.

DIAGNOSTIC_TEST

Preimplantation genetic test

The cells removed from an in vitro fertilization embryo during the trophectoderm biopsy will be tested for chromosomal normalcy before transferring the embryo to the uterus.

PROCEDURE

Embryo transfer

Embryo transfer refers to a step in the process of assisted reproduction in which embryos are placed into the uterus

DIAGNOSTIC_TEST

Pregnancy test

A pregnancy test is used to determine whether a woman is pregnant.

PROCEDURE

Embryo freezing

Embryo freezing is a method for cryopreserving embryos.

PROCEDURE

Embryo thawing

Embryo thawing is the procedure to recover previously frozen embryos prior to an embryo transfer.

Sponsors & Collaborators

• IVI Madrid

  lead OTHER

Principal Investigators

• Maria Cerrillo, M.D., Ph.D. · IVI Madrid

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

42 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-01

Primary Completion

2019-12-01

Completion

2020-06-01

Countries

• Spain

Study Locations