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Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT03120715 (opens ClinicalTrials.gov in a new tab)Other idNFEC-2017-024
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
342 participants (estimated)
Sponsor
Nanfang Hospital, Southern Medical University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
1 Jul 2016
Primary completion
30 Jun 2017 (estimated)
Completion
5 Sept 2017 (estimated)
First posted
19 Apr 2017
Last update posted
19 Apr 2017
Conditions
Infertility

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 4

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

    NCT03120715

    1 Jul 2016 to est. 5 Sept 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • estrogenDrug
  • Low Molecular Weight HeparinDrug
  • hCGDrug
  • progesteroneDrug

Arms2

  • Placebo comparator

    NLMWH-A

    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).

  • Experimental

    LMWH-B

    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).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Clinical pregnancy rate

    Time frame · 4-6 weeks

    Registry description

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

Secondary outcomes(3)

  1. Implantation rate

    Time frame · 4-6 weeks

    Registry description

    Evaluation the implantation rate in patients of each groups 4-6 weeks after frozen embryo transfer

  2. Ongoing pregnancy

    Time frame · 12 weeks

    Registry description

    Evaluation the ongoing pregnancy by monitoring pregnant bursa and fetal heart through ultrasound in patients of each group 12 weeks after embryo transfer.

  3. miscarriage rate

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

    Registry description

    12 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 43 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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