Clinical trial NCT03898037: Effect of Lifestyle and/or Metformin Intervention on Pregnancy Outcome, A Pilot Randomized Controlled Trial
Official title: Effect of Lifestyle and/or Metformin Intervention on Pregnancy Outcome in Overweight/Obese Non-pcos Infertility Women With Insulin Resistance , A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Obesity
Insulin Resistance
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: recruitment rate
timeFrame: 10 months
Secondary outcomes:
measure: mean numbers of randomised participants per month
timeFrame: 10 months
measure: the proportion of participants with good intervention compliance
timeFrame: 16 months
measure: the proportion of participants who crossed over from one allocated group to the other
timeFrame: 16 months
measure: Proportion of subjects who initiated infertility treatment according to the schedule
timeFrame: 16 months
measure: the proportion of participants who completed follow-up
timeFrame: 26 months
measure: Biochemical Pregnancy Rate
timeFrame: 16 months
measure: Clinical Pregnancy Rate
timeFrame: 18 months
measure: Live Birth Rate
timeFrame: 26 months
measure: Birth weight
timeFrame: 26 months
measure: Pregnancy Loss Rate
timeFrame: 26 months
measure: Incidence of moderate to severe ovarian hyperstimulation syndrome(OHSS)
timeFrame: 16 months
measure: Cumulative incidence of maternal and neonatal complications during whole gestation and prenatal stage
timeFrame: 26 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive & Genetic Hospital of CITIC-XIANGYA
state: Hunan
Study officials:
References: