NCT02325479

Brief Summary

Heparin also has the ability to bind with and modulate a wide variety of proteins, which can influence a number of physiological processes involved in implantation \& trophoblastic development. These processes include adhesion of the blastocyst to the endometrial surface \& trophoblastic differentiation \& invasion. A recent Cochrane review hinted towards research to study the possible effects of the local (uterine), \& NOT SYSTEMIC application of heparin during Assisted reproductive technology (ART). Based on the above evidence the investigators hypothesize that low molecular weight heparin given intrauterine at mock embryo transfer after oocyte pick up will help improve pregnancy rates in patients undergoing ART.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

December 17, 2014

Last Update Submit

February 17, 2016

Conditions

Infertility

Keywords

Low Molecular Weight (LMWH) Heparin ICSI Enaoxaprin sodium

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

    safety

    14 days

Secondary Outcomes (2)

  • Early miscarriage rate

    12 weeks

  • Implanation rate

    3 weeks after ET

Study Arms (2)

Group A

EXPERIMENTAL

After scheduled oocyte pick up, a mock embryo transfer will be done using labotec catheter (Labotec, Gottingen Germany), and an injection of Enaoxaprin sodium (LMWH) (Clexane® Sanofi S.A Paris, France) will be given intrauterine in group A patients, 500 IU of LMWH which is 5mg, in 0.05 ml.

Drug: Enaoxaprin sodium

Group B

PLACEBO COMPARATOR

The control arm (group B) will be injected intrauterine with similar volume of tissue culture media (G.2 plus ref. 10132, Vitrolife)

Drug: tissue culture media

Interventions

Enaoxaprin sodiumDRUG

intrauterine administration after oocyte pickup as the main experimental intervention

Also known as: Clexane
Group A
tissue culture mediaDRUG

intrauterine administration after oocyte pickup as placebo

Also known as: (G.2 plus ref. 10132, Vitrolife)
Group B

Eligibility Criteria

Age20 Years - 37 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal serum prolactin level \& thyroid stimulating hormone (TSH)
  • Unexplained infertility
  • Tubal factor infertility
  • BMI \<30 kg/m2

You may not qualify if:

  • Reduced ovarian reserve by AFC, Anti-mullerian hormone (AMH)
  • Presence of non disconnected hydrosalpinges
  • Frozen embryo transfer cycles
  • Uterine Anomalies
  • Submucous fibroids and polyps
  • Uterine synechia
  • Contraindication of pregnancy e.g.: Somatic and mental diseases, which are contraindications for carrying of a pregnancy and childbirth, inborn malformations or acquired deformations of uterus cavity which make embryo implantation or carrying of a pregnancy impossible ,ovarian tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Egyptian IVF-ET Center

Cairo, Maadi, 11431, Egypt

Location

Related Publications (2)

  • Akhtar MA, Sur S, Raine-Fenning N, Jayaprakasan K, Thornton J, Quenby S, Marjoribanks J. Heparin for assisted reproduction: summary of a Cochrane review. Fertil Steril. 2015 Jan;103(1):33-4. doi: 10.1016/j.fertnstert.2014.09.005. Epub 2014 Oct 1.

    PMID: 25282470BACKGROUND

  • Mansour R, Tawab N, Kamal O, El-Faissal Y, Serour A, Aboulghar M, Serour G. Intrauterine injection of human chorionic gonadotropin before embryo transfer significantly improves the implantation and pregnancy rates in in vitro fertilization/intracytoplasmic sperm injection: a prospective randomized study. Fertil Steril. 2011 Dec;96(6):1370-1374.e1. doi: 10.1016/j.fertnstert.2011.09.044. Epub 2011 Nov 1.

    PMID: 22047664BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Mona M Aboulghar, M.D

    IVF consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Obstetrics and Gynecology Fetal Medicine unit Cairo University, IVF Consultant Egyptian IVF center -Maadi Cairo

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 25, 2014

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

December 1, 2015

Last Updated

February 18, 2016

Record last verified: 2016-02

Locations

EG(1)