Insemination in patients with polycystic ovary syndrome: gestation rates using two stimulation patterns: letrozole vs gonadotropins.

Start 15 Dec 2023 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol LEGOIN

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruiting

Participants planned 100

Countries 1

Sites 1

Insemination in patients with polycystic ovary syndrome

The main objective of the research study is to know if letrozole is a therapeutic alternative to gonadotropins in artificial inseminations in patients with polycystic ovary in terms of gestation rate and live birth rate.

Key facts

Sponsor: Hospital Universitario La Paz
Participant type: Patients
Age range: 18-64 years
Gender: Female
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Trial duration: 15 Dec 2023 → ongoing
Decision date (initial): 2023-10-09
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Secondary objectives 6

To examine the results of the cycles in terms of clinical miscarriage rate.
To examine the results of the cycles in terms of bioquimical miscarriage rate.
To examine the results of the cycles in terms of cycle cancellation due to non-response.
To examine the results of the cycles in terms of cycle cancellation due to hyper-response.
To analyze if there is a different duration of treatment and a greater number of dominant follicles recruited comparing both patterns.
To analyze if these differences are observed in both conjugal and donor inseminations.

Conditions and MedDRA coding

Insemination in patients with polycystic ovary syndrome

Study design 1 period

#	Title	Allocation	Blinding	Roles blinded	Arms
1	Phase 3, unicenter, randomized, controlled, open-label, parallel group, prospective study Phase 3, unicenter, open label study	Randomised Controlled	None		EXPERIMENTAL GROUP: Letrozol 2.5 mg film-coated tablets: EXPERIMENTAL GROUP: Letrozol 2.5 mg film-coated tablets CONTROL GROUP: rFSH 50-75 IU subcutaneous injections: CONTROL GROUP: rFSH 50-75 IU subcutaneous injections

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

Age: women between 18-40 years old.
Body mass index (BMI): ≥18 and ≤30.
Primary or secondary infertility.
Diagnosis of PCOS according to Rotterdam criteria (The Rotterdam ESHRE/ASRM- sponsored PCOS Consensus Workshop Group Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod 2004; 19: 41-47).
Insemination indication.
Women giving informed consent to participate in the study.

Exclusion criteria 13

Women with BMI <18 or >30.
Women in in vitro fertilization program.
Presence of uterine malformations.
Presence of polymyomatous uterus, with the exception of subserosal or intramural myomas <5cm that do not deform the uterine cavity.
Moderate and severe endometriosis.
History or presence of Pelvic Inflammatory Disease.
Interventions on cervix that may have originated a stenosis and/or cervical stenosis at the beginning of the study.
Unexcised or occluded hydrosalpinx.
Existence of severe male factor: cryptozoospermia or oligoasthenoteratozoospermia or with low REM (< 5 million).
Presence of any systemic disease or poorly controlled endocrinological pathology that may interfere with the objectives of the study.
Verification by vaginal ultrasound of the presence of any residual follicle or corpus luteum.
Patients who have not responded to letrozole in ovulation induction cycles.
Contraindication to the use of any of the treatments foreseen by the study in the terms established in the protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

The gestation rate is calculated as the number of gestations (determined as positive urine pregnancy test between the 15th-17th day of insemination) per insemination performed.
The rate of new borns is calculated as the number of newborns per insemination performed.

Secondary endpoints 13

Number of dominant follicles recruited, defined as the number of follicles larger than 14 mm visualized on the last day of ultrasound control performed on the patient prior to insemination.
Cancellation due to non-response (defined as no response to stimulation treatment after 28 days of stimulation, defined as the non-observation of dominant follicles (larger than 14 mm) on vaginal ultrasound.
Cancellation due to hyperresponse (defined as the presence of 3 or more follicles larger than 14mm on the day of ultrasound control).
Abortion rate: defined as the loss of pregnancy before 20 weeks of gestational age per gestation achieved.
Biochemical pregnancy rate defined as the termination of a pregnancy before the gestational sac is detected by ultrasound.
Insulin resistance: Peripheral insulin resistance is calculated using the formula HOMA IR= IB*GB/22.5. Its cut-off point is 3.8. or a glucose overload of 75 gr positive. A test is performed with 75 gr. of glucose administered on an empty stomach and controlled blood glucose levels at two hours. If the value is between 140 and 199 mg/dl then it is called Glucose Intolerance.
BMI: is calculated by dividing the kilograms of weight by the square of the height in meters (BMI = weight (kg)/ [height (m)]2
Antimullerian hormone: the determination of AMH (ECLIA Roche Diagnostics)
Incidence of gestational diabetes
Perinatal data
Route of delivery: eutocic, instrumental o cesarean
Newborn weight
Days of stimulation: stimulation days defined as the number of days until ovulatory discharge.