The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers

The Effect of LMWH on ICSI Outcome in Patients With Unexplained Infertility and Negative Immunological Markers; a Randomized Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02861105

Enrollment

716

Registered

2016-08-10

Start date

2015-01-31

Completion date

2016-03-31

Last updated

2016-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unexplained Infertility

Brief summary

The purpose of this study is to assess the efficacy of LMWH treatment in women with unexplained infertility and negative immunological markers undergoing ICSI.

Detailed description

Inclusion criteria: 1. patients undergoing 1st trial ICSI 2. unexplained infertility 3. negative immunological markers including ACL abs, LAC, ANA, ATA, AnitdsDNA Exclusion criteria: 1. previous IVF/ICSI 2. Any cause of infertility 3. Suspected and/or unexpected poor response during ovulation induction 4. positive immunological markers 5. Age \> 40 years. All participants will undergo IVF/ICSI cycle using the Long luteal phase protocol. the dose of gonadotropins will be calculated according to patient age and BMI. All patients will have 2-3 embryos transferred at D5 according to their age. the primary outcome will be LBR. secondary outcomes will include biochemical pregnancy rate and clinical pregnancy rate.

Interventions

DRUGLMWH

LMWH will be given on daily basis subcutaneously every 24 hours starting one day after ovum pick up till documentation of fetal life by ultrasound at 7 weeks.

OTHER0.9% saline solution

0.9% saline solution will be given subcutaneously every 24 hours starting one day after ovum pick up till documentation of fetal life by ultrasound at 7 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 38 Years

Healthy volunteers

Inclusion criteria

* age less than 38 years * at least 12 months of infertility * women with unexplained infertility

Exclusion criteria

* age more than or equals 38 years * serum AMH level less than or equals 1 ng/ml * patients of anticoagulant therapy * immune-compromised patients * patients with contraindications to low molecular weight heparin * positive immunological markers * patients with other than unexplained infertility * male factor infertility * refusal of participation * patients with unexpected poor or over response during induction of ovulation

Design outcomes

Primary

Measure	Time frame
Live birth Rate	at delivery

Secondary

Measure	Time frame
Clinical Pregnancy Rate	at 7 weeks of gestation
Biochemical Pregnancy Rate	14 days after embryo transfer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026