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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04081870
• Other study ID #: khalid 6
• Status: Completed
• Start date: February 2014
• Est. completion date: May 2019

Study information

• Verified date: September 2019
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

References & Publications (1)

Lédée-Bataille N, Laprée-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. — View Citation

Outcome

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