Does pre-pregnancy levothyroxine treatment will improve the in vitro fertilization outcomes? A randomized placebo controlled clinical trial

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-15007426
• Date of registration: 2015-11-20
• Prospective Registration: Yes
• Primary sponsor: Center for Reproductive Medicine, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
• Public title: Does pre-pregnancy levothyroxine treatment will improve the in vitro fertilization outcomes? A randomized placebo controlled clinical trial
• Scientific title: Does pre-pregnancy levothyroxine treatment will improve the in vitro fertilization outcomes? A randomized placebo controlled clinical trial
• Date of first enrolment: 2016-01-01
• Target sample size: Levothyroxine arm:181;Placebo arm:181;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=12531
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Zi-Jiang Chen

• Name: Zi-Jiang Chen
• Affiliation: Center for Reproductive Medicine, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Women have a duration of infertility >=1 year;
2. Women ages >=20 and <40 years old;
3. Women who are undergoing their first cycle of IVF or ICSI;
4. Women with TSH level 2.5~4mIU/L and normal free thyroxine.
Exclusion criteria: 1. Women who are taking thyroid medicine or medicines interfering thyroid metabolism for last 2 months;
2. Women who have previously been diagnosed with a uterine abnormality such as a malformed uterus (uterus unicornis, septate uterus, duplex uterus or uterus bicomis), adenomyosis, submucous myoma or intrauterine adhesion;
3. Women or their partners with an abnormal chromosome karyotype;
4. Women with medical conditions that contraindicate assisted reproductive technology and/or pregnancy, such as poorly controlled diabetes mellitus; undiagnosed liver disease or dysfunction (based on serum liver enzyme test results); undiagnosed renal disease or abnormal serum renal function; severe anemia; history of deep venous thrombosis, pulmonary embolus or cerebrovascular accident; uncontrolled hypertension or symptomatic heart disease; history of (or suspected) cervical carcinoma, endometrial carcinoma or breast carcinoma; and undiagnosed vaginal bleeding.

Age minimum: 20
Age maximum: 39
Gender: Female

Health Condition(s) or Problem(s) studied

Subclinical hypothyroidism, infertility

Intervention(s)

Levothyroxine arm:Levothyroxine treatment;Placebo arm:Placebo;

Primary Outcome(s)

Live birth rate;children IQ at 60 months old;

Source(s) of Monetary Support

?