Trial · Interventional

CompletedPhase 4Results postedRegistry data

Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success

NCTNCT02606500Other idMerck-01

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names hCG (human chorionic gonadotropin), does not test it. It appears in the description.

Overview

Status: Completed
Phase: Phase 4
Enrollment: 70 participants (actual)
Sponsor: University Medical Centre Ljubljana · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
Slovenia
Start: Mar 2016
Primary completion: Jan 2017
Completion: Mar 2017
First posted: 17 Nov 2015 (estimated)
Last update posted: 26 Nov 2018
Conditions: Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201620172018

Ph 4
Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success
NCT02606500
Mar 2016 to Mar 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The aim of the present study is to determine, whether clinical efficacy of 150 mcg of Corifollitropin alfa is the same in normal weighing and obese women. Furthermore, investigators want to determine whether oocytes retrieved from normal weighing and obese women, after COH using 150 mcg of Corifollitropin alfa, are of same quality on the molecular level.

Interventions

ElonvaDrug

Arms2

Experimental
Elonva 150 mcg
Elonva 150 mcg intramuscular daily obese
Active comparator
Elonva 100 mcg
Elonva 100 mcg intramuscular daily normal weight

Primary outcomes5

Outcomes the sponsor listed as primary.

Number of Oocytes Retrieved Per Patient
Time frame · 1 month
Registry description
Number of oocytes obtained in the study group was compared to the number of oocytes obtained in the control group
Number of Mature Oocytes
Time frame · 1 month
Registry description
Number of mature oocytes obtained was compared between groups
Number of Fertilized Oocytes
Time frame · 1 month
Number of Frozen Embryos
Time frame · 1 month
Biochemical Pregnancy Rate
Time frame · 1 year

Secondary outcomes(1)

Real-time PCR Analysis of Genes That Were Proposed as Biomarkers of Oocyte Quality to Determine Effect of Corifollitropin Alpha on Oocyte Quality on Molecular Level
Time frame · 12 months
Registry description
Expression of some genes that were proposed as biomarkers of oocyte quality was analysed in CC using real-time PCR. Relative expression values of genes were compared between mature oocytes derived from obese women and mature oocytes derived from normal weighing women.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 1 month

Number of Oocytes Retrieved Per Patient

Group	Value (Oocytes)	Spread
Study Group	11.3	7.5
Control Group	12.4	7.4

Primary outcomeNumber· 1 month

Number of Mature Oocytes

Group	Value (Mature oocytes)
Study Group	269
Control Group	319

Primary outcomeNumber· 1 month

Number of Fertilized Oocytes

Group	Value (Fertilized oocytes)
Study Group	206
Control Group	207

Primary outcomeNumber· 1 month

Number of Frozen Embryos

Group	Value (Frozen embryos)
Study Group	45
Control Group	49

Primary outcomeNumber· 1 year

Biochemical Pregnancy Rate

Group	Value (Biochemical pregnancies)
Study Group	18
Control Group	18

Secondary and other outcome results(1)

Secondary outcomeMean· 12 months

Real-time PCR Analysis of Genes That Were Proposed as Biomarkers of Oocyte Quality to Determine Effect of Corifollitropin Alpha on Oocyte Quality on Molecular Level

Group	Value (Arbitrary units (Relative expression))	Spread
Study Group	2.52	1.73
Control Group	1.31	0.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Study Group35 obese women (BMI ≥ 30 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR. Inclusion criteria for the study group were: first or second IVF cycle, BMI ≥ 30 kg/m2, tubal factor of infertility, normal partner's spermiogram.	–	0 / 35	0 / 35
Control Group35 normal weighing women (BMI 19 - 24.9 kg/m2) were included to the study group. 150 mcg of Elonva for controlled ovarian hyperstimulation (COH) on day 2 or 3 of menstrual cycle. GnRH antagonist was used to prevent premature LH surge. Additional daily doses of 200 IU of rFSH were used if necessary to achieve optimal ovarian stimulation. hCG was used to induce final oocyte maturation. Follicles were aspirated separately in each patient. Cumulus cells (CC) samples of the first 2 aspirated follicles were collected and stored on -80 oC for subsequent analyses. Clinical IVF parameters were assessed and compared between the groups. Also, gene expression analyses of CC were performed using quantitative real-time PCR. Inclusion criteria for the control group were: first or second IVF cycle, normal BMI (19 - 24.9 kg/m2), tubal factor of infertility and normal partner's spermiogram.	–	0 / 35	0 / 35

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 38 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * BMI \> 30 kg/m2 * BMI 18.5-24.9 kg/m2 Exclusion Criteria: * polycystic ovary syndrome, severely abnormal sperm parameters, and age \> 38 years

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