IS Three d Power Doppler of the Endometrial and Subendometrial Regions Effective in Predicting Endometrial Implantation?

IS Three d Power Doppler of the Endometrial and Subendometrial Regions Effective?

Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day (progest, micronized progesterone 100mg, Technopharma, Egypt, for pharco pharmaceuticals, Amriya- Alexandria). Five days following ovum pick up, the embryos were transferred at the blastocyst stage.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Diagnostic test: 3D power doppler US

Detailed Description

All women underwent long agonist protocol for controlled ovarian hyperstimulation described by Chang et al. (14) The GnRH agonist was started in the previous mid-luteal phase (decapeptylR R 0.1mg, Triptorelin-Acetate, Ferring GmbH, Wittland 11, D-24109, and Kiel, Germany). After the confirmation of pituitary down regulation (serum LH less than 5 m IU/ml and serum E2 less than 50 pg /ml), the HMG ampoules were started by 225 IU/day (Gonapure 75 IU, IBSA Institute Biochimique SA, Switzerland). During the follow up of overstimulation, the doses were adjusted according to the response of patient. All women underwent serial TVS until at least three dominant follicles were reached in every woman. When the dominant follicles reached 18-20 mm, HCG 10000 (Choriomon 5000 IU, IBSA Institute Biochimique SA, Switzerland) was administered. Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day (progest, micronized progesterone 100mg, Technopharma, Egypt, for pharco pharmaceuticals, Amriya- Alexandria). Five days following ovum pick up, the embryos were transferred at the blastocyst stage. Twelve days later to embryo transfer, serum pregnancy test was done and if positive (chemical pregnancy), the clinical pregnancy was confirmed by TVS for detection of gestational sacs and embryo cardiac activity. The ongoing pregnancy was detected by abdominal ultrasound at 12 weeks.

• Study Type: Observational
• Enrollment (Actual): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

infertile women in need for ICSI due to male factor

Description

Inclusion Criteria:

a

• age; 22-35 years,
• BMI; less than 35 kg/m2,
• Husband with oligo- or oligoasthenospermia.

Exclusion Criteria:

• \1-gross uterine and tubal pathology,
• 2-Development of OHSS,
• 3-poor responders,
• 4-failure of oocyte fertilization or failure of the embryos to reach the blastocyst stage and
• 5-Refusal to participate in the study at any step of the ICSI cycle.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

ICSI cases; All women underwent long agonist protocol for controlled ovarian hyperstimulation The GnRH agonist was started in the previous mid-luteal phase . After the confirmation of pituitary down regulation , the HMG ampoules were started by 225 IU/day . During the follow up of overstimulation, the doses were adjusted according to the response of patient. All women underwent serial TVS until at least three dominant follicles were reached in every woman. When the dominant follicles reached 18-20 mm, HCG 10000 was administered. Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day . Five days following ovum pick up, the embryos were transferred at the blastocyst stage.

Diagnostic test: 3D power doppler US; Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chemical pregnancy	positive pregnancy test	14 day
the clinical pregnancy	was confirmed by TVS for detection of gestational sacs and embryo cardiac activity.	28 day
The ongoing pregnancy	was detected by abdominal ultrasound at 12 weeks.	3 months

Collaborators and Investigators

• Sponsor: Benha University

Publications and helpful links

General Publications

• Ledee-Bataille N, Lapree-Delage G, Taupin JL, Dubanchet S, Frydman R, Chaouat G. Concentration of leukaemia inhibitory factor (LIF) in uterine flushing fluid is highly predictive of embryo implantation. Hum Reprod. 2002 Jan;17(1):213-8. doi: 10.1093/humrep/17.1.213.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2014
• Primary Completion (ACTUAL): April 1, 2019
• Study Completion (ACTUAL): May 1, 2019

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (ACTUAL): September 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: doppler,endometrial,implantation
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: khalid 6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No