Effect of Lifestyle and/or Metformin Intervention on Pregnancy Outcome, A Pilot Randomized Controlled Trial

Reproductive & Genetic Hospital of CITIC-Xiangya80 enrolled

Overview

The purpose of pilot trial is to compare the efficacy of lifestyle intervention, metformin intervention, lifestyle combined with metformin intervention in improving assisted reproductive technology in non-polycystic ovary syndrome(pcos) patients with overweight/obesity and insulin resistance compared with conventional clinical education. Subjects who meet the inclusion criteria will be randomized to four groups: lifestyle intervention group, metformin intervention group, lifestyle combined with metformin intervention group, and routine clinical education group. Subjects of above three intervention group will start ovulation stimulation treatment after reach the aim or duration of intervention and routine clinical education group has no intervention. All subjects are treated with the same procedures, including a long ovarian stimulation regimen, oocyte retrieval, and fertilization, followed by a planned transfer of two day-3 embryos. The primary outcome is ongoing pregnancy rate.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infertility, Female Obesity Insulin Resistance

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 36 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Women ages 18 to 36 years. 2. Women BMI at least 25kg/m2. 3. Women who are non-pcos patient(2003 Rotterdam criteria). 4. Women with insulin resistance (HOMA criteria). 5. Women who are participating in their first or second fresh embryo cycle of in- vitro fertilization(IVF) or intracytoplasmic sperm injection (ICSI). 6. Women who are indicated IVF or ICSI. Exclusion Criteria: 1. Women with endometriosis. 2. Women with untreated hydrosalpinx. 3. Women with a uterine cavity abnormality, such as a uterine congenital malformation; untreated uterine septum(except shallow uterine septum), adenomyosis, submucous myoma, or intrauterine adhesions. 4. Women who are indicated and planned to undergo preimplantation genetic diagnosis(PGD)/preimplantation genetic screening(PGS). 5. Women with endocrine abnormalities, such as Cushing syndrome, congenital adrenal hyperplasia, pituitary amenorrhea, thyroid dysfunction etc. 6. Women who had participated in other treatments known to affect diet or weight (such as diet drugs and dietitian intervention) for past 3 months. 7. Women who are unable to follow verbal and written instructions. 8. Women who use donated oocytes to achieve pregnancy. 9. Women with poor ovarian response(Bologna criteria). 10. Women with diabetes mellitus, abnormal glycosylated hemoglobin. 11. Women who has a history of recurrent spontaneous abortion.

Outcomes

Primary Outcomes

recruitment rate

the proportion of eligible patients randomised

Time frame: 10 months

Secondary Outcomes

mean numbers of randomised participants per month

numbers of randomised participants / the duration of recruitment

Time frame: 10 months

the proportion of participants with good intervention compliance

numbers of participants with good intervention compliance / numbers of participants who received the intervention

Time frame: 16 months

the proportion of participants who crossed over from one allocated group to the other

numbers of participants who crossed over from one allocated group to the other / numbers of participants who received the intervention

Time frame: 16 months

Proportion of subjects who initiated infertility treatment according to the schedule

numbers of participants who initiated infertility treatment according to the schedule/ numbers of participants who received the intervention

Time frame: 16 months

the proportion of participants who completed follow-up

numbers of participants who completed follow-up/ numbers of participants who received the intervention

Time frame: 26 months

Biochemical Pregnancy Rate

Number of women with Biochemical pregnancy /number of women who received the intervention Biochemical pregnancy was defined as a human chorionic gonadotropin level of more than 10 milli-International unit（mIU）per milliliter（ml）, as measured at about 14 days after embryo transfer.

Time frame: 16 months

Clinical Pregnancy Rate

Number of women with clinical pregnancies /number of women who received the intervention. Clinical pregnancy was defined as the presence of a gestational sac in the uterine cavity at about 28 days after embryo transfer, as detected on ultrasonography.

Time frame: 18 months

Live Birth Rate

Numbers of Live birth /number of women who received the intervention.Live birth defined as the delivery of any viable infant at 28 weeks or more of gestation.

Time frame: 26 months

Birth weight

Weight of newborns at delivery.

Time frame: 26 months

Pregnancy Loss Rate

Number of pregnancy losses / number of clinical pregnancies. Pregnancy loss refers to a complete spontaneous abortion or a nonviable pregnancy before 28 weeks of gestation.

Time frame: 26 months

Incidence of moderate to severe ovarian hyperstimulation syndrome(OHSS)

Number of cycles of moderate to severe OHSS/total number of fresh stimulation cycle.

Time frame: 16 months

Cumulative incidence of maternal and neonatal complications during whole gestation and prenatal stage

Number of pregnancies with complications / number of pregnancies; Number of live births with neonatal complications / number of live births；

Time frame: 26 months

Effect of Lifestyle and/or Metformin Intervention on Pregnancy Outcome, A Pilot Randomized Controlled Trial

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes