Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation

Short name FASHION

NCTNCT02449889Other id000191

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 176 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Randomized · Single masking
Countries: 1 country
Brazil
Start: Apr 2016
Primary completion: 9 Jul 2017
Completion: 1 Mar 2018
First posted: 20 May 2015 (estimated)
Last update posted: 26 Jun 2019
Conditions: Infertility

Timeline

1 trial · 1 completed · 1 with posted results

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

2016201720182019

Ph 3
FASHION
NCT02449889
Apr 2016 to 1 Mar 2018

Registry summary

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

This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing controlled ovarian stimulation

Interventions

highly purified human chorionic gonadotropinDrug
recombinant human chorionic gonadotropinDrug

Arms3

Experimental
HP-hCG IM
highly purified human chorionic gonadotropin, intramuscularly (IM)
Experimental
HP-hCG SC
highly purified human chorionic gonadotropin, subcutaneously (SC)
Active comparator
rhCG
recombinant human chorionic gonadotropin

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Oocytes Retrieved
Time frame · Approximately 36 hours after hCG administration
Registry description
Oocyte retrieval took place 36 h (±2h) after hCG administration. At oocyte retrieval the number of oocytes retrieved was recorded.

Secondary outcomes(6)

Number of Metaphase II (MII) Oocytes
Time frame · Prior to insemination (within 6 hours after oocyte retrieval)
Registry description
Only applicable for insemination using intracytoplasmic sperm injection (ICSI). The MII oocytes were counted prior to insemination.
Number of Fertilized (2 Pronuclei (2PN)) Oocytes
Time frame · One day after oocyte retrieval
Registry description
Fertilization was assessed by counting the number of pronuclei, which was recorded as 0, 1, 2 or \>2. Correct fertilization was defined as oocytes with 2PN.
Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate
Time frame · 13-15 days after transfer
Registry description
Defined as percentage of subjects with positive beta hCG. A positive β hCG was confirmed by a blood test obtained 13-15 days after transfer.
Clinical Pregnancy Rate
Time frame · 5-6 weeks after transfer
Registry description
Defined as percentage of subjects with clinical pregnancy. Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.
Frequency of Adverse Events (AEs)
Time frame · AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented
Registry description
The number of treatment-emergent AEs (TEAEs) in each treatment group will be presented.
Intensity of AEs
Time frame · AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.
Registry description
The intensity of an TEAE would be classified using the following 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity \[disturbing\]) or severe (inability to work or perform usual activities \[unacceptable\]).

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· Approximately 36 hours after hCG administration

Number of Oocytes Retrieved

Group	Value (Number of oocytes)	Spread
HP-hCG IM	7.1	4.6
HP-hCG SC	7.3	4.8
rhCG SC	6.6	4.1

Secondary and other outcome results(6)

Secondary outcomeMean· Prior to insemination (within 6 hours after oocyte retrieval)

Number of Metaphase II (MII) Oocytes

Group	Value (Number of MII oocytes)	Spread
HP-hCG IM	5.9	3.7
HP-hCG SC	6.2	3.5
rhCG SC	5.6	3.3

Secondary outcomeMean· One day after oocyte retrieval

Number of Fertilized (2 Pronuclei (2PN)) Oocytes

Group	Value (Number of fertilized oocytes)	Spread
HP-hCG IM	4.4	3.3
HP-hCG SC	4.7	3.4
rhCG SC	4.2	2.7

Secondary outcomeNumber· 13-15 days after transfer

Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate

Group	Value (percentage of participants)
HP-hCG IM	50.0
HP-hCG SC	37.9
rhCG SC	36.7

Secondary outcomeNumber· 5-6 weeks after transfer

Clinical Pregnancy Rate

Group	Value (percentage of participants)
HP-hCG IM	46.6
HP-hCG SC	27.6
rhCG SC	31.7

Secondary outcomeNumber· AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented

Frequency of Adverse Events (AEs)

Group	Value (Number of AEs)
HP-hCG IM	22
HP-hCG SC	25
rhCG SC	25

Secondary outcomeCount of participants· AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.

Intensity of AEs

Group	Value (Participants)
HP-hCG IM	14
HP-hCG SC	18
rhCG SC	22

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
HP-hCG IMHighly purified human chorionic gonadotropin 5000 international units (IU), intramuscularly (IM) Highly purified human chorionic gonadotropin	0 / 58	1 / 58	12 / 58
HP-hCG SCHighly purified human chorionic gonadotropin, 5000 IU subcutaneously (SC) Highly purified human chorionic gonadotropin	0 / 58	1 / 58	12 / 58
rhCGRecombinant human chorionic gonadotropin 250 µg SC Recombinant human chorionic gonadotropin	0 / 60	2 / 60	11 / 60

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 39 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Pre-menopausal females between the ages of 18 and 39 years * Documented history of infertility * Body mass index (BMI) between 17.5 and 32.0 kg/m2 * Regular menstrual cycles Exclusion Criteria: * Known endometriosis stage III and IV * Known polycystic ovarian syndrome (PCOS) * History of recurrent miscarriage * History of more than three previous controlled ovarian stimulation cycles

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