Please select the eligibility criteria that correspond to the clinical trial below.
Title: "Evaluation of Clinical Outcomes and Costs of a Transferable Interdisciplinary Lifestyle Intervention Pre- and Per-pregnancy in Obese Infertile Women"
Brief Summary: BACKGROUND: Obesity increases the risk of polycystic ovary syndrome (PCOS), characterized by anovulatory cycles, but it is also associated with reduced fertility even in ovulatory women. Moreover, obesity increases the costs of assisted human reproduction (AHR) treatments and reduces their efficacy. In addition to fertility disorders, obesity increases significantly the risks of many complications of pregnancy, delivery and neonatal health. However, a modest loss of 5-10% of total body weight can restore ovulation and improve pregnancy rates.

OBJECTIVES: 1) To design and implement a multidisciplinary program for lifestyle management of obese women, or overweight women with PCOS, who seek fertility treatment in a secondary AHR center. 2) To evaluate lifestyle benefits of this program and assess its impact on fertility, pregnancy and neonatal outcomes, as compared to a randomly assigned control group and to similar women seen in tertiary AHR centers. 3) To assess cost per live birth, and other measures of cost-effectiveness, of this program compared to the control group and tertiary AHR centers. 4) To effectively transfer knowledge obtained through these activities to relevant stakeholders in the health care and public health sectors.

METHODS AND APPROACH: In order to design the program for lifestyle management of obesity in infertile women, we will gather a Committee composed of members of our interdisciplinary research team and relevant collaborators. Objectives 2 and 3 - In order to achieve these objectives, 128 obese women (BMI ≥ 30 kg/m²), or overweight women with PCOS (BMI ≥ 27 kg/m²), consulting at the CHUS fertility clinic will be randomized to our lifestyle program, and will suspend fertility treatments for six months, or to standard fertility treatments, which are directly initiated. The results obtained will also be compared to those of women with the same criteria who will consult in 3 tertiary AHR clinics not offering a similar lifestyle management program.

IMPACT: This project is very important as it will generate new knowledge about the implementation, impacts and costs of a new lifestyle management program in obese infertile women. Our project will obtain valuable data on implementability of such a program; on benefits with regard to lifestyle, fertility and maternal and foetal complications during pregnancy; as well as on reduction in cost per live birth and other cost-effectiveness ratio.


Options:
A: Inclusion Criteria:

* Obese (BMI ≥ 30kg/m2) infertile women
* Overweight (BMI ≥ 27kg/m2) infertile women with polycystic ovary syndrome

Exclusion Criteria:

* Women older than 40 years old
* Women who went through bariatric surgery
* Women under IVF
* Women for whome IVF is the only recommended treatment
* Women who do not speak french
B: Inclusion Criteria:

* Women aged from 18 to 40 years old.
* PCOS diagnosis (according to Rotterdam criteria).
* Mild or moderate male factor, tubal factor or unknown infertility.

Exclusion Criteria:

* Follicle stimulation hormone (third of day of menstruation) \> 10 milli international units/L.
* Endometriosis (III o IV).
* Congenital adrenal hyperplasia.
* Cushing syndrome.
* Hyperprolactinemia.
* Thyroid disease.
* Androgenic hormone secretor tumors.
* Patients included in this trial did not take either oral contraceptives, steroids or other medications that could modify the ovarian function, insulin sensitivity or lipid metabolism 3 months before the onset of the trial.
* Severe male factor (sperm concentration \< 5 mill/ml).
* Patients undergoing oocyte vitrification to avoid hyperstimulation syndrome will be excluded.
C: Inclusion Criteria:

* body mass index (weight in kg/height in cm squared) \>25
* accepted for assisted fertilization treatment at St.Olav's hospital

Exclusion Criteria:

* low responders, defined as AMH \<2 pmol/L or \< 5 oocytes in prior in vitro fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) cycles or antral follicle count (AFC) \< 5
* current or previous Metformin use (a wash-out period of \> four weeks)
D: Inclusion Criteria:

* Women with a pregnancy wish within 1 year;
* Aged 18-40 years;
* Overweight/obesity (BMI ≥ 25 kg/m2).

Exclusion Criteria:

* Haemodynamically significant heart disease;
* Restrictive lung disease;
* Congenital metabolic disease;
* Mentally retarded;
* Bariatric surgery;
* Diabetes type II, dependent on medicine.

Answer: A