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

NCT03898037 | Completed

• 1 other identifier: P2019001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female; Obesity; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• recruitment rate

  the proportion of eligible patients randomised

  10 months

Secondary Outcomes (12)

• mean numbers of randomised participants per month

  10 months

• the proportion of participants with good intervention compliance

  16 months

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

  16 months

• Proportion of subjects who initiated infertility treatment according to the schedule

  16 months

• the proportion of participants who completed follow-up

  26 months

Study Arms (4)

lifestyle intervention group

EXPERIMENTAL

Subjects will receive weight loss intervention under the guidance of a dietitian after assigned to lifestyle intervention group, including: restricted energy balanced diet, aerobic exercise, etc. Subjects will come to the hospital to measure their height, weight, waist circumference, hip circumference, body fat rate, BMI and test oral glucose tolerance test (OGTT)/insulin resistance test(IRT)/HOMA, blood routine, liver and kidney function on the day of grouping and in the 4th week, the 8th week, the 12th week after grouping. The aim is to lose 5-10% of the initial body weight. If the target was reached within 3 months, subjects will receive ovarian stimulation treatment in advance, otherwise treatment starts after 3 months. 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 pregnancy and perinatal outcomes after transfer were followed up.

Behavioral: weight loss intervention

metformin intervention group

EXPERIMENTAL

Subjects will be given metformin intervention with a starting dose of 0.5g bid after assigned to metformin intervention group, and the dose will be adjusted by doctors according to the insulin level and adverse events. Subjects will come to the hospital to measure their height, weight, waist circumference, hip circumference, body fat rate, BMI and test OGTT/IRT/HOMA, blood routine, liver and kidney function on the day of grouping and the 4th week, the 8th week, the 12th week after grouping. The aim is to adjust insulin level to normal within 3 months. If the target was reached within 3 months, subjects will start to receive ovarian stimulation treatment in advance, Otherwise treatment starts after 3 months. 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 etc. The pregnancy and perinatal outcomes after transfer were followed up.

Drug: metformin intervention

lifestyle combined with metformin intervention group

EXPERIMENTAL

Subjects will receive weight loss intervention and metformin intervention after assigned to lifestyle combined with metformin intervention group. Subjects will come to the hospital to measure their height, weight, waist circumference, hip circumference, body fat rate, BMI and test OGTT/IRT/HOMA, blood routine, liver and kidney function on the day of grouping and in the 4th week, the 8th week, the 12th week after grouping. The aim is to lose 5-10% of the initial body weight and adjust insulin level to normal within 3 months. If the target was reached within 3 months, subjects will receive ovarian stimulation treatment in advance, otherwise treatment starts after 3 months. 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 etc. The pregnancy and perinatal outcomes after transfer were followed up.

Behavioral: weight loss intervention; Drug: metformin intervention

routine clinical education group

NO INTERVENTION

Subjects will only accept clinical routine education after assigned to routine clinical education group. Subjects will measure their height, weight, waist circumference, hip circumference, body fat rate, BMI and test OGTT/IRT/HOMA, blood routine, liver and kidney function on the day of grouping and will start induced ovulation therapy after completing routine clinical examination. 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 etc. The pregnancy and perinatal outcomes after transfer were followed up.

Interventions

weight loss intervention BEHAVIORAL

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

lifestyle combined with metformin intervention group; lifestyle intervention group

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.

lifestyle combined with metformin intervention group; metformin intervention group

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reproductive & Genetic Hospital of CITIC-Xiangya: lead

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410008, China

Location

Related Publications (1)

• Wang X, Cai S, Tang S, Yang L, Tan J, Sun X, Gong F. Effect of lifestyle or metformin interventions before IVF/ICSI treatment on infertile women with overweight/obese and insulin resistance: a factorial design randomised controlled pilot trial. Pilot Feasibility Stud. 2023 Sep 12;9(1):160. doi: 10.1186/s40814-023-01388-x.

  PMID: 37700375 DERIVED

MeSH Terms

Conditions

Infertility, Female; Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 1, 2019
• Study Start: June 13, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

CN (1)