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

Obesity Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898037
• Other study ID #: P2019001
• Status: Completed
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2022
• Source: Reproductive & Genetic Hospital of CITIC-Xiangya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Insulin Resistance
• Obesity

Intervention

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

Drug:
• metformin intervention
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.

Locations

Country	Name	City	State
China	Reproductive & Genetic Hospital of CITIC-XIANGYA	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recruitment rate	the proportion of eligible patients randomised	10 months
Secondary	mean numbers of randomised participants per month	numbers of randomised participants / the duration of recruitment	10 months
Secondary	the proportion of participants with good intervention compliance	numbers of participants with good intervention compliance / numbers of participants who received the intervention	16 months
Secondary	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	16 months
Secondary	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	16 months
Secondary	the proportion of participants who completed follow-up	numbers of participants who completed follow-up/ numbers of participants who received the intervention	26 months
Secondary	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.	16 months
Secondary	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.	18 months
Secondary	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.	26 months
Secondary	Birth weight	Weight of newborns at delivery.	26 months
Secondary	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.	26 months
Secondary	Incidence of moderate to severe ovarian hyperstimulation syndrome(OHSS)	Number of cycles of moderate to severe OHSS/total number of fresh stimulation cycle.	16 months
Secondary	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;	26 months