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

• Status: Completed
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
• Treatments: Insulin; Insulin, Globin Zinc; Metformin

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.