Dienogest Versus GnRH-a Pre-treatment in Women With Endometriosis Undergoing IVF
Status:
Unknown status
Trial end date:
2020-02-22
Target enrollment:
Participant gender:
Summary
Endometriosis is a chronic gynecologic disease that affects approximately 10% of women in the
reproductive age group . It is characterized by the presence of endometrial tissue outside
the uterus, causing pelvic pain and subfertility. It is estimated that around 40% of
infertile women have the diagnosis of endometriosis . Infertility secondary to endometriosis
is thought to be multifactorial. Women with endometriosis often require in vitro
fertilization (IVF). One medical intervention that has been shown to improve IVF outcomes in
women with endometriosis is hormonal suppression with gonadotropic releasing hormone agonist
(GnRH-a) for a period of 3 to 6 months .
In recent years, the effectiveness of dienogest, a fourth-generation progestin, for
endometriosis treatment has been demonstrated. Dienogest seems to be as effective as GnRH-a
in improving endometriosis-related pelvic pain [4]. However, no study has yet assessed
whether dienogest has any benefit in treating endometriosis associated infertility.
The aim of our study is to evaluate the efficacy of dienogest versus GnRH-a in improving
ongoing pregnancy rates in women undergoing IVF due to endometriosis. We will conduct a
non-blinded randomized controlled trial. One group will receive dienogest 2mg daily for a
period of 3 months followed by a standard IVF/Intracytoplasmic Sperm Injection (ICSI) cycle.
The second group will receive one injection of 3.75mg of GnRH-a every 28 days for three doses
followed by a standard IVF/ICSI cycle 3 months later. The third group will not receive any
medical interventions before the planned IVF/ICSI cycle. We hypothesize that patients
receiving dienogest will have similar ongoing pregnancy rates compared to patients receiving
the GnRH-a injection. Secondary outcomes including number of gonadotropins consumed, number
of stimulation days, number of metaphase II eggs retrieved, fertilization rate, embryo
quality, miscarriage rate, clinical pregnancy rates, live birth rates and potential maternal
and obstetrical complications will also be evaluated. We will also compare ongoing pregnancy
rates between the groups receiving Dienogest and placebo, and GnRH agonist and placebo.