Pregnancy Outcome of Women Using Low Molecular Weight Heparin Before Frozen-thawed Embryo Transfer

NCT03120715 | Unknown Phase 4 DMC

• 1 other identifier: NFEC-2017-024
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief Summary

Embryo freezing is a technique used commonly to optimize the pregnancy rate in assisted reproduction techniques (ART). Hormone replacement therapy (HRT) regimen is applied to prepare endometrium for frozen embryo transfer (FET) commonly.At present, It is unclear whether preimplantation low molecular weight heparin (LMWH) improves live birth and pregnancy rates in subfertile women undergoing FET. The study is a prospective randomized controlled trial to compare the pregnancy outcomes of FET in hormonal replacement therapy(HRT) cycles with or without LMWH administration before implantation.

Conditions

Infertility

Keywords

low molecular weight heparin (LMWH); frozen embryo transfer (FET); pregnancy

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  The pregnancy rate will be evaluated in patients of each groups 4-6 weeks after embryo transfer.

  4-6 weeks

Secondary Outcomes (3)

• Implantation rate

  4-6 weeks

• Ongoing pregnancy

  12 weeks

• miscarriage rate

  Evaluation the miscarriage rate in patients of each group 12 weeks after embryo transfer.

Study Arms (2)

NLMWH-A

PLACEBO COMPARATOR

non-low molecular weight heparin-group A(group NLMWH-A).Without administration of low molecular weight heparin (LMWH) before FET.The oral estrogen replacement is 4mg per day (2 mg twice daily), 4 days; 6 mg per day, 4 days. Then, the patient's endometrial thickness is evaluated through vaginal ultrasound and if the endometrial thickness is \<7 mm, increasing estrogen by 2 mg is given to patients until the endometrial thickness is \>9 mm.If the endometrial thickness is greater than 9 mm, Human Chorionic Gonadotropin（hCG） 10000 IU will be administered via intramuscular injection.on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3).

Drug: estrogen; Drug: hCG; Drug: progesterone

LMWH-B

EXPERIMENTAL

low molecular weight heparin-group B(group LMWH-B).With administration of low molecular weight heparin (LMWH) before FET.The oral estrogen replacement is 4mg per day (2 mg twice daily), 4 days; 6 mg per day, 4 days. Then, the patient's endometrial thickness is evaluated through vaginal ultrasound and if the endometrial thickness is \<7 mm, increasing estrogen by 2 mg is given to patients until the endometrial thickness is \>9 mm.If the endometrial thickness is greater than 9 mm, Human Chorionic Gonadotropin（hCG） 10000 IU will be administered via intramuscular injection.on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3).

Drug: estrogen; Drug: Low Molecular Weight Heparin; Drug: hCG; Drug: progesterone

Interventions

estrogen DRUG

The oral estrogen replacement is 4mg per day (2 mg twice daily), 4 days; 6 mg per day, 4 days. Then, the patient's endometrial thickness is evaluated through vaginal ultrasound and if the endometrial thickness is \<7 mm, increasing estrogen by 2 mg is given to patients until the endometrial thickness is \>9 mm.

Also known as: estrodiol

LMWH-B; NLMWH-A

Low Molecular Weight Heparin DRUG

If the endometrial thickness is greater than 9 mm, hCG 10000 IU will be administered via intramuscular injection.And low molecular weight heparin (LMWH) will be injected subcutaneously 4100 IU (WHO) every other day before FET.Then on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3).

Also known as: LMWH

LMWH-B

hCG DRUG

If the endometrial thickness is greater than 9 mm, Human Chorionic Gonadotropin（hCG） 10000 IU will be administered via intramuscular injection.

Also known as: Human Chorionic Gonadotropin

LMWH-B; NLMWH-A

progesterone DRUG

on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3).

LMWH-B; NLMWH-A

Eligibility Criteria

• Age: 20 Years - 43 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 20 to 43 years;
• Body mass index (BMI) between 19 kg/m2 and 25 kg/m2;
• At least one good quality D3 embryos for transfer;
• prepare endometrium by hormone replacement therapy(HRT)protocal;
• capable of giving informed consent.

You may not qualify if:

• Women or their partner with abnormal chromosome karyotype including chromosome polymorphism;
• Women diagnosed as uterus abnormality: malformed uterus (uterus unicorns, septate uterus, duplex uterus, uterus bicornis), adenomyosis, submucous myoma, intrauterine adhesion;
• Women who underwent unilateral ovariectomy or with history of ovarian tumor surgery ;
• infection factors: TORCH virus (including Toxoplasma virus, rubella virus, cytomegalovirus,herpes simplex infection),Chlamydia and Mycoplasma, etc;
• Endometriosis;
• Having hydrosalpinx ;
• Low molecular weight heparin contraindications: thrombocytopenia, hemophilia and other bleeding disorders, liver and kidney dysfunction, with a clear history of heparin allergy or allergic constitution, etc.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Estrogens; Heparin, Low-Molecular-Weight; Chorionic Gonadotropin; Progesterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Gonadotropins; Peptide Hormones; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Xin Chen, M.D, Ph.D

  Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Chen, M.D, Ph.D

CONTACT

8620-61641908; zhiduoxinrun@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 19, 2017
• Study Start: July 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: September 5, 2017
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

CN (1)