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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Unexplained Infertility

Treatments: Drug: LMWH; Other: 0.9% saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02861105

ASU-OG-333

Details and patient eligibility

About

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

Full 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.

Enrollment: 716 patients

Sex: Female

Ages: Under 38 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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716 participants in 2 patient groups, including a placebo group

LMWH supplementation

Active Comparator group

Description:

40 mg of enoxaparin injected subcutaneously every 24 hours starting the day of ovum pick-up to the documentation of fetal life by ultrasound at 7 weeks of gestation

Treatment:

Drug: LMWH

0.9% saline solution

Placebo Comparator group

Description:

0.9% saline injected subcutaneously every 24 hours starting the day of ovum pick-up to the documentation of fetal life by ultrasound at 7 weeks of gestation

Treatment:

Other: 0.9% saline solution