Clinical trial NCT04081870: IS Three d Power Doppler of the Endometrial and Subendometrial Regions Effective in Predicting Endometrial Implantation?
Official title: IS Three d Power Doppler of the Endometrial and Subendometrial Regions Effective?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: doppler,endometrial,implantation
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infertile women in need for ICSI due to male factor

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: chemical pregnancy
timeFrame: 14 day
measure: the clinical pregnancy
timeFrame: 28 day
measure: The ongoing pregnancy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Benha University
name: khalid salama
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.