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Completed

NCT Number: NCT03898037

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

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.

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Key information

Conditions

Infertility, Female Body Weight Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Hyperinsulinism Infertility Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410008, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women ages 18 to 36 years.
  • Women BMI at least 25kg/m2.
  • Women who are non-pcos patient(2003 Rotterdam criteria).
  • Women with insulin resistance (HOMA criteria).
  • Women who are participating in their first or second fresh embryo cycle of in- vitro fertilization(IVF) or intracytoplasmic sperm injection (ICSI).
  • Women who are indicated IVF or ICSI.

Exclusion criteria

  • Women with endometriosis.
  • Women with untreated hydrosalpinx.
  • 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.
  • Women who are indicated and planned to undergo preimplantation genetic diagnosis(PGD)/preimplantation genetic screening(PGS).
  • Women with endocrine abnormalities, such as Cushing syndrome, congenital adrenal hyperplasia, pituitary amenorrhea, thyroid dysfunction etc.
  • Women who had participated in other treatments known to affect diet or weight (such as diet drugs and dietitian intervention) for past 3 months.
  • Women who are unable to follow verbal and written instructions.
  • Women who use donated oocytes to achieve pregnancy.
  • Women with poor ovarian response(Bologna criteria).
  • Women with diabetes mellitus, abnormal glycosylated hemoglobin.
  • Women who has a history of recurrent spontaneous abortion.

Treatment and study plan

Weight loss intervention

Behavioral

weight loss intervention under the guidance of a dietitian, including: restricted energy balanced diet, aerobic exercise, etc.

metformin intervention

Drug

metformin intervention with a starting dose of 0.5g bid, and the dose will be adjusted by doctors according to the patient's insulin level and adverse events.

Primary outcomes

  1. recruitment rate

    Time frame: 10 months

    the proportion of eligible patients randomised

Secondary outcomes

  1. mean numbers of randomised participants per month

    Time frame: 10 months

    numbers of randomised participants / the duration of recruitment

  2. the proportion of participants with good intervention compliance

    Time frame: 16 months

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

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

    Time frame: 16 months

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

  4. Proportion of subjects who initiated infertility treatment according to the schedule

    Time frame: 16 months

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

  5. the proportion of participants who completed follow-up

    Time frame: 26 months

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

  6. Biochemical Pregnancy Rate

    Time frame: 16 months

    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.

  7. Clinical Pregnancy Rate

    Time frame: 18 months

    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.

  8. Live Birth Rate

    Time frame: 26 months

    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.

  9. Birth weight

    Time frame: 26 months

    Weight of newborns at delivery.

  10. Pregnancy Loss Rate

    Time frame: 26 months

    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.

  11. Incidence of moderate to severe ovarian hyperstimulation syndrome(OHSS)

    Time frame: 16 months

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

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

    Time frame: 26 months

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

Sponsors and collaborators

Lead sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2019
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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